{ "code": "DXY", "deviceName": "Implantable Pacemaker Pulse-Generator", "deviceClass": "III", "regulationNumber": "870.3610", "panel": "Cardiovascular", "definition": null, "submissionTypeId": "2", "submissionType": "510(k)", "clearances": { "total": 461, "last12Months": 0 }, "adverseEvents": { "total": 2506, "last12Months": 561 }, "reviewDays": { "median": 56, "sampleSize": 461 }, "recalls": { "total": 75, "recent": [ { "resNumber": "Z-1495-2022", "status": "Open, Classified", "recallClass": "Class II", "firm": "St. Jude Medical, Cardiac Rhythm Management Division", "firmAsPublished": "St. Jude Medical, Cardiac Rhythm Management Division", "reason": "There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.", "initiated": "2022-06-17" }, { "resNumber": "Z-1496-2022", "status": "Open, Classified", "recallClass": "Class II", "firm": "St. Jude Medical, Cardiac Rhythm Management Division", "firmAsPublished": "St. Jude Medical, Cardiac Rhythm Management Division", "reason": "The Merlin\" 2 PCS model MER3700 is a portable, dedicated programming\nsystem designed to interrogate, program, display data from, and test Abbott\nMedical implantable medical devices during implant and follow-up.", "initiated": "2022-06-17" }, { "resNumber": "Z-1497-2022", "status": "Open, Classified", "recallClass": "Class II", "firm": "St. Jude Medical, Cardiac Rhythm Management Division", "firmAsPublished": "St. Jude Medical, Cardiac Rhythm Management Division", "reason": "The Merlin\" 2 PCS model MER3700 is a portable, dedicated programming\nsystem designed to interrogate, program, display data from, and test Abbott\nMedical implantable medical devices during implant and follow-up.", "initiated": "2022-06-17" }, { "resNumber": "Z-0030-2018", "status": "Terminated", "recallClass": "Class II", "firm": "St. Jude Medical, Inc.", "firmAsPublished": "St Jude Medical Inc.", "reason": "New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.", "initiated": "2017-08-28" }, { "resNumber": "Z-0031-2018", "status": "Terminated", "recallClass": "Class II", "firm": "St. Jude Medical, Inc.", "firmAsPublished": "St Jude Medical Inc.", "reason": "New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.", "initiated": "2017-08-28" } ] }, "recentClearances": [ { "kNumber": "K993434", "deviceName": "PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A", "applicant": "Biotronik, Inc.", "company": "BIOTRONIK, Inc.", "decisionDate": "1999-11-10", "dateReceived": "1999-10-12" }, { "kNumber": "K970072", "deviceName": "OPUS S MODEL 4121 AND 4124 PACEMAKERS", "applicant": "Ela Medical, Inc.", "company": "Ela Medical, Inc.", "decisionDate": "1997-08-29", "dateReceived": "1997-01-08" }, { "kNumber": "K945627", "deviceName": "PIKOS LP 01, PIKOS LP E01", "applicant": "Biotronik, Inc.", "company": "BIOTRONIK, Inc.", "decisionDate": "1996-03-04", "dateReceived": "1994-11-16" }, { "kNumber": "K954092", "deviceName": "ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)", "applicant": "Medtronic Vascular", "company": "Medtronic Vascular", "decisionDate": "1995-12-15", "dateReceived": "1995-08-10" }, { "kNumber": "K953866", "deviceName": "MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)", "applicant": "Medtronic Vascular", "company": "Medtronic Vascular", "decisionDate": "1995-12-15", "dateReceived": "1995-08-10" }, { "kNumber": "K953417", "deviceName": "MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS", "applicant": "Cook Pacemaker Corp.", "company": "Cook Pacemaker Corp.", "decisionDate": "1995-09-29", "dateReceived": "1995-06-08" }, { "kNumber": "K952328", "deviceName": "NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01", "applicant": "Biotronik, Inc.", "company": "BIOTRONIK, Inc.", "decisionDate": "1995-09-29", "dateReceived": "1995-05-18" }, { "kNumber": "K952364", "deviceName": "OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)", "applicant": "Ela Medical, Inc.", "company": "Ela Medical, Inc.", "decisionDate": "1995-09-01", "dateReceived": "1995-05-01" }, { "kNumber": "K940039", "deviceName": "PELLETHANE 75D", "applicant": "Medtronic Vascular", "company": "Medtronic Vascular", "decisionDate": "1995-07-12", "dateReceived": "1994-01-04" }, { "kNumber": "K950751", "deviceName": "TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES", "applicant": "Medtronic Vascular", "company": "Medtronic Vascular", "decisionDate": "1995-05-15", "dateReceived": "1995-02-17" } ], "topApplicants": [ { "name": "Medtronic Vascular", "count": 59 }, { "name": "Intermedics, Inc.", "count": 52 }, { "name": "Telectronics, Inc.", "count": 47 }, { "name": "Cardiac Pacemakers, Inc.", "count": 37 }, { "name": "Pacesetter Systems", "count": 28 } ], "topCompanies": [ { "name": "Medtronic Vascular", "count": 59, "spellings": 1 }, { "name": "Intermedics, Inc.", "count": 52, "spellings": 1 }, { "name": "Telectronics, Inc.", "count": 47, "spellings": 1 }, { "name": "Cardiac Pacemakers, Inc.", "count": 37, "spellings": 1 }, { "name": "Pacesetter Systems", "count": 28, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2023-01-01", "observed": 40, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 46, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 31, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 40, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 54, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 47, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 47, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 266, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 67, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 61, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 59, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 60, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 59, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 52, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 63, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 71, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 76, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 50, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 97, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 65, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 60, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 64, "expectedLow": 41.62696479417954, "expectedHigh": 79.90949282762037, "isSufficient": true }, { "month": "2025-02-01", "observed": 36, "expectedLow": 37.03263141191916, "expectedHigh": 70.49233280588915, "isSufficient": true }, { "month": "2025-03-01", "observed": 69, "expectedLow": 32.47994074642397, "expectedHigh": 75.98302764532745, "isSufficient": true }, { "month": "2025-04-01", "observed": 92, "expectedLow": 37.2101803293273, "expectedHigh": 84.03276273331517, "isSufficient": true }, { "month": "2025-05-01", "observed": 75, "expectedLow": 37.85603180013215, "expectedHigh": 93.21105038904467, "isSufficient": true }, { "month": "2025-06-01", "observed": 51, "expectedLow": 42.50750827584589, "expectedHigh": 99.73516917194446, "isSufficient": true }, { "month": "2025-07-01", "observed": 81, "expectedLow": 55.71238362334778, "expectedHigh": 148.78889295275243, "isSufficient": true }, { "month": "2025-08-01", "observed": 64, "expectedLow": 36.49524602155303, "expectedHigh": 108.58750947964509, "isSufficient": true }, { "month": "2025-09-01", "observed": 67, "expectedLow": 35.024749810150944, "expectedHigh": 111.54203766775454, "isSufficient": true }, { "month": "2025-10-01", "observed": 66, "expectedLow": 35.00839710575933, "expectedHigh": 108.1081845468634, "isSufficient": true }, { "month": "2025-11-01", "observed": 50, "expectedLow": 32.5019754014161, "expectedHigh": 92.75875063690286, "isSufficient": true }, { "month": "2025-12-01", "observed": 80, "expectedLow": 30.044814355785363, "expectedHigh": 100.14712080764623, "isSufficient": true }, { "month": "2026-01-01", "observed": 95, "expectedLow": 40.09781543887842, "expectedHigh": 120.8391122406074, "isSufficient": true }, { "month": "2026-02-01", "observed": 61, "expectedLow": 36.946618082416705, "expectedHigh": 105.82495246122828, "isSufficient": true }, { "month": "2026-03-01", "observed": 99, "expectedLow": 40.15965261310444, "expectedHigh": 110.59031491150238, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "DXY (Implantable Pacemaker Pulse-Generator): 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%3ADXY" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXY" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXY" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADXY" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADXY" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADXY" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADXY" } ], "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": "2026-08-11T13:51:45.687Z" }