FDA Adverse Event
Injury
Summary report: N
VITALITY DR
MDR report key: 750837
·
Received August 9, 2006
Report
- Report Number
- 2124215-2006-14968
- Event Type
- Injury
- Date Received
- August 9, 2006
- Date of Event
- April 20, 2006
- Report Date
- April 20, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED APRIL 24, 2003, DISPLAYED AN END OF LIFE (EOL) INDICATOR. THERE IS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. IT IS REPORTED THAT THE CHARGE TIME WAS 30, PATIENT WAS PACING 93% OF THE TIME AND THE PACING THRESHOLDS WERE [email protected]. THE PACING IMPEDANCE WAS NORMAL AT 600 OHMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | 1871 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |