FDA Adverse Event
Malfunction
Summary report: N
VITALITY DS
MDR report key: 750977
·
Received August 9, 2006
Report
- Report Number
- 2124215-2006-14828
- Event Type
- Malfunction
- Date Received
- August 9, 2006
- Date of Event
- April 12, 2006
- Report Date
- April 12, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED ON JULY 19, 2005, HAD A MONITORING VOLTAGE (MV) OF 3.24V AT IMPLANT. THE CURRENT FOLLOW-UP MEASURED A MV OF 3.0V, WITH A BATTERY STATUS OF BEGINNING-OF-LIFE (BOL). THE PATIENT HAS AD NO UNUSUAL PACING OR SHOCKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY DS | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T125 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |