FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2
MDR report key: 2172897
·
Received July 22, 2011
Report
- Report Number
- 2124215-2011-10211
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 9, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. A REQUEST WAS MADE TO HAVE THE DEVICE RETURNED FOR ANALYSIS POST EXPLANT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FIVE MONTHS AGO, THIS DEVICE BATTERY INDICATOR WAS STILL AT BEGINNING OF LIFE (BOL) STATUS WITH A MONITORING VOLTAGE OF 3.10 AND CHARGE TIME OF 8.4 SECONDS. THEN, FOUR MONTHS LATER THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A MONITORING VOLTAGE OF 2.97 AND CHARGE TIME OF 13.1 SECONDS. THE DEVICE IS SCHEDULED FOR REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | T177| 0185 |