FDA Adverse Event
Malfunction
Summary report: N
INSIGNIA
MDR report key: 1851285
·
Received October 4, 2010
Report
- Report Number
- 2124215-2010-13982
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 1, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Removal / Correction Number
- Z-0187-06 THRU Z-0190-06
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED AS NECESSARY.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS HEALTH CARE PROFESSIONAL REPORTED THAT THREE MONTHS AGO, THIS DEVICE BATTERY SHOWED ONE YEAR REMAINING WITH A MAGNET RATE OF 100BPM. DURING A HOME MONITORING CHECK, THE MAGNET RATE WAS DOWN TO 85BPM. TECHNICAL SERVICES DISCUSSED THEY MAY WANT TO CHECK THE TELETRANSPHONIC MONITORING AGAIN TO VERIFY IT WAS AN ACTUAL MAGNET RATE OR BRING THE PATIENT IN TO VERIFY IF THE DEVICE IS AT ELECTIVE REPLACEMENT TIME (ERT) AND WHEN THAT OCCURRED. TECHNICAL SERVICES DISCUSSED PATIENT'S RISKS IF THIS DEVICE IS EXHIBITING ANY BATTERY DEPLETION ANOMALIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | 4034| 1298| 4063| 4469| 1283 |