FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 DR
MDR report key: 711190
·
Received May 9, 2006
Report
- Report Number
- 2124215-2006-13147
- Event Type
- Malfunction
- Date Received
- May 9, 2006
- Date of Event
- January 12, 2006
- Report Date
- January 12, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT, PRIOR TO IMPLANT, THE BATTERY VOLTAGE OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TESTED WELL BELOW BOL (BEGINNING OF LIFE) AND WAS THUS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T165 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |