VALITUDE? X4 CRT-P
Report
- Report Number
- 2124215-2025-28793
- Event Type
- Death
- Date Received
- May 5, 2025
- Date of Event
- March 14, 2025
- Report Date
- July 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NKE
- UDI-DI
- 00802526559402
- PMA / PMN Number
- P030005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS. THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.
IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) RECORDED A YELLOW ALERT IN THE REMOTE MONITORING SYSTEM FOR AN ARRHYTHMIA ON (B)(6) 2025. THE DATA WAS TRANSMITTED ON (B)(6) 2025, BUT THE ALERT WAS RECEIVED BY THE CLINIC TWO DAYS LATER. BASED ON THE ELECTROGRAM (EGM) IN THE VT EPISODE, IT APPEARED THE PATIENT HAD EXPIRED. TECHNICAL SERVICES REVIEWED THE EPISODE AND AGREED WITH THE HEALTH CARE PROFESSIONAL (HCP) AND RECOMMENDED A WELLNESS CHECK. THE PATIENT WAS FOUND DECEASED IN THEIR HOME ON (B)(6) 2025. LATITUDE CUSTOMER SUPPORT WAS CONTACTED AND DETERMINED THE REASON THE ALERT WAS DELAYED IS THAT THE DATA APPEARS TO HAVE BEEN TRAPPED IN THE COMMUNICATOR UNTIL IT PERFORMED A POWER CYCLE. THE DEVICE WAS SUBSEQUENTLY RECEIVED FOR ANALYSIS. A NOTE ON THE DEATH CERTIFICATE INDICATED THE CAUSE OF DEATH WAS ASYSTOLE DUE TO "PACEMAKER FAILURE" OR MYOCARDIAL INFARCTION, CAUSED BY CORONARY ARTERY DISEASE AND HEART FAILURE. THE MANNER OF DEATH WAS LISTED AS NATURAL. AN ALLEGATION AGAINST THE IMPLANTED DEVICE WAS NOT ABLE TO BE RULED OUT AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE DEVICE ANALYSIS IS COMPLETED.
IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) RECORDED A YELLOW ALERT IN THE REMOTE MONITORING SYSTEM FOR AN ARRHYTHMIA ON (B)(6) 2025. THE DATA WAS TRANSMITTED ON (B)(6) 2025, BUT THE ALERT WAS RECEIVED BY THE CLINIC TWO DAYS LATER. BASED ON THE ELECTROGRAM (EGM) IN THE VT EPISODE, IT APPEARED THE PATIENT HAD EXPIRED. TECHNICAL SERVICES REVIEWED THE EPISODE AND AGREED WITH THE HEALTH CARE PROFESSIONAL (HCP) AND RECOMMENDED A WELLNESS CHECK. THE PATIENT WAS FOUND DECEASED IN THEIR HOME ON (B)(6) 2025. LATITUDE CUSTOMER SUPPORT WAS CONTACTED AND DETERMINED THE REASON THE ALERT WAS DELAYED IS THAT THE DATA APPEARS TO HAVE BEEN TRAPPED IN THE COMMUNICATOR UNTIL IT PERFORMED A POWER CYCLE. THE DEVICE WAS SUBSEQUENTLY RECEIVED FOR ANALYSIS. A NOTE ON THE DEATH CERTIFICATE INDICATED THE CAUSE OF DEATH WAS ASYSTOLE DUE TO "PACEMAKER FAILURE" OR MYOCARDIAL INFARCTION, CAUSED BY CORONARY ARTERY DISEASE AND HEART FAILURE. THE MANNER OF DEATH WAS LISTED AS NATURAL. AN ALLEGATION AGAINST THE IMPLANTED DEVICE WAS NOT ABLE TO BE RULED OUT AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE DEVICE ANALYSIS IS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99071 | VALITUDE? X4 CRT-P | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) | NKE | BOSTON SCIENTIFIC CORPORATION | U128 | 742036 | 00802526559402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Death |