FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 DR
MDR report key: 711763
·
Received May 9, 2006
Report
- Report Number
- 2124215-2006-14379
- Event Type
- Malfunction
- Date Received
- May 9, 2006
- Date of Event
- March 22, 2006
- Report Date
- March 22, 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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A MONITORING VOLTAGE OF 2.64V (MIDDLE OF LIFE 2) WITH NORMAL PACING ENERGY AND NO DELIVERED SHOCKS. THE DEVICE WAS IMPLANTED 11 MONTHS.
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 | 83 YR | Other |