{
  "code": "DTB",
  "deviceName": "Permanent Pacemaker Electrode",
  "deviceClass": "III",
  "regulationNumber": "870.3680",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "2",
  "submissionType": "510(k)",
  "clearances": {
    "total": 487,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 83720,
    "last12Months": 16370
  },
  "reviewDays": {
    "median": 79,
    "sampleSize": 487
  },
  "recalls": {
    "total": 8,
    "recent": [
      {
        "resNumber": "Z-0022-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Medtronic Inc. Cardiac Rhythm Disease Management",
        "firmAsPublished": "Medtronic Inc. Cardiac Rhythm Disease Management",
        "reason": "Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance  (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.",
        "initiated": "2015-09-15"
      },
      {
        "resNumber": "Z-0287-2011",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Greatbatch Medical",
        "firmAsPublished": "Greatbatch Medical",
        "reason": "The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.",
        "initiated": "2010-05-13"
      },
      {
        "resNumber": "Z-1200-2010",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Medtronic Inc. Cardiac Rhythm Disease Managment",
        "firmAsPublished": "Medtronic Inc. Cardiac Rhythm Disease Managment",
        "reason": "Medtronic has identified a packaging issue  for a subset of Epicardial Leads Model 5071.  They determined that specific package seals could be compromised.  Medtronic is not aware of any patient injury due to this packaging issue and their evaluation indicated the risk of patient injury is remote.  However, a compromised package seal could potentially affect product sterility.",
        "initiated": "2010-02-25"
      },
      {
        "resNumber": "Z-0580-2010",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Greatbatch Medical",
        "firmAsPublished": "Greatbatch Medical",
        "reason": "The silicone tubing of affected leads was processed outside of validated parameters.  Although the material remains biocompatible, test data regarding the performance characteristics are not available.",
        "initiated": "2009-09-01"
      },
      {
        "resNumber": "Z-0581-2010",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Greatbatch Medical",
        "firmAsPublished": "Greatbatch Medical",
        "reason": "The silicone tubing of affected leads was processed outside of validated parameters.  Although the material remains biocompatible, test data regarding the performance characteristics are not available.",
        "initiated": "2009-09-01"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K061212",
      "deviceName": "BIOTRONIK ENDOCARDIAL PACING LEADS",
      "applicant": "Biotronik, Inc.",
      "company": "BIOTRONIK, Inc.",
      "decisionDate": "2006-07-10",
      "dateReceived": "2006-05-01"
    },
    {
      "kNumber": "K041809",
      "deviceName": "PERMANENT PACING LEAD, MODEL PY2",
      "applicant": "Oscor, Inc.",
      "company": "Oscor, Inc.",
      "decisionDate": "2004-08-06",
      "dateReceived": "2004-07-06"
    },
    {
      "kNumber": "K040569",
      "deviceName": "PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU",
      "applicant": "Oscor, Inc.",
      "company": "Oscor, Inc.",
      "decisionDate": "2004-04-07",
      "dateReceived": "2004-03-04"
    },
    {
      "kNumber": "K031274",
      "deviceName": "MODEL 5071 MYOCARDIAL PACING LEAD",
      "applicant": "Medtronic Vascular",
      "company": "Medtronic Vascular",
      "decisionDate": "2003-05-22",
      "dateReceived": "2003-04-22"
    },
    {
      "kNumber": "K031210",
      "deviceName": "MODEL 4951M MYOCARDIAL UNIPOLAR LEAD",
      "applicant": "Metronic, Inc.",
      "company": "Metronic, Inc.",
      "decisionDate": "2003-05-16",
      "dateReceived": "2003-04-17"
    },
    {
      "kNumber": "K023205",
      "deviceName": "ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP",
      "applicant": "Biotronik, Inc.",
      "company": "BIOTRONIK, Inc.",
      "decisionDate": "2003-04-24",
      "dateReceived": "2002-09-25"
    },
    {
      "kNumber": "K024053",
      "deviceName": "PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB",
      "applicant": "Oscor, Inc.",
      "company": "Oscor, Inc.",
      "decisionDate": "2003-01-31",
      "dateReceived": "2002-12-09"
    },
    {
      "kNumber": "K023803",
      "deviceName": "MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS",
      "applicant": "Biotronik, Inc.",
      "company": "BIOTRONIK, Inc.",
      "decisionDate": "2002-12-11",
      "dateReceived": "2002-11-14"
    },
    {
      "kNumber": "K023099",
      "deviceName": "AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP",
      "applicant": "Biotronik, Inc.",
      "company": "BIOTRONIK, Inc.",
      "decisionDate": "2002-10-18",
      "dateReceived": "2002-09-18"
    },
    {
      "kNumber": "K021217",
      "deviceName": "AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP",
      "applicant": "Biotronik, Inc.",
      "company": "BIOTRONIK, Inc.",
      "decisionDate": "2002-05-01",
      "dateReceived": "2002-04-17"
    }
  ],
  "topApplicants": [
    {
      "name": "Intermedics, Inc.",
      "count": 105
    },
    {
      "name": "Medtronic Vascular",
      "count": 69
    },
    {
      "name": "Telectronics, Inc.",
      "count": 35
    },
    {
      "name": "Pacesetter Systems",
      "count": 33
    },
    {
      "name": "Daig Corp.",
      "count": 28
    }
  ],
  "topCompanies": [
    {
      "name": "Intermedics, Inc.",
      "count": 105,
      "spellings": 1
    },
    {
      "name": "Medtronic Vascular",
      "count": 69,
      "spellings": 1
    },
    {
      "name": "Telectronics, Inc.",
      "count": 35,
      "spellings": 1
    },
    {
      "name": "Pacesetter Systems",
      "count": 33,
      "spellings": 1
    },
    {
      "name": "Daig Corp.",
      "count": 28,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 2060,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 1953,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 2146,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1943,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 2469,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 2296,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 2357,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 7766,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 2310,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 2254,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 2117,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 2221,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 2417,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 2087,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 1805,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 2260,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 2171,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1949,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 2301,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2172,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1935,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1859,
        "expectedLow": 1502.6196422298435,
        "expectedHigh": 2304.6525173684095,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 1874,
        "expectedLow": 1298.1440901153828,
        "expectedHigh": 1992.3603586798602,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 1783,
        "expectedLow": 1524.8605552785864,
        "expectedHigh": 2315.1090436060517,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 2150,
        "expectedLow": 1558.2220023303514,
        "expectedHigh": 2331.6344259041953,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 2349,
        "expectedLow": 1638.5661260913946,
        "expectedHigh": 2111.6392526015943,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 2129,
        "expectedLow": 1695.3783988365929,
        "expectedHigh": 2485.7181979439674,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 2364,
        "expectedLow": 2669.5282169879592,
        "expectedHigh": 3944.4487171044357,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 1943,
        "expectedLow": 1707.528314793957,
        "expectedHigh": 2861.610491194375,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 2551,
        "expectedLow": 1651.119209685638,
        "expectedHigh": 2937.4229748549046,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 2287,
        "expectedLow": 1722.447589526751,
        "expectedHigh": 2995.0132485229915,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 1912,
        "expectedLow": 1530.5601759765655,
        "expectedHigh": 2682.8780019974038,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 1818,
        "expectedLow": 1610.303062594488,
        "expectedHigh": 2919.967744147216,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 2165,
        "expectedLow": 1638.6819487317903,
        "expectedHigh": 3283.862872084627,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 1902,
        "expectedLow": 1269.8034210059554,
        "expectedHigh": 2753.5218851943614,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 2228,
        "expectedLow": 1352.9457918032779,
        "expectedHigh": 2974.112292620225,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DTB (Permanent Pacemaker Electrode): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3ADTB"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADTB"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADTB"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADTB"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADTB"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADTB"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADTB"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.682Z"
}