FDA Adverse Event
Malfunction
Summary report: N
VITALITY AVT
MDR report key: 710965
·
Received May 9, 2006
Report
- Report Number
- 2124215-2006-13358
- Event Type
- Malfunction
- Date Received
- May 9, 2006
- Date of Event
- January 25, 2006
- Report Date
- January 25, 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) DECLARED END OF LIFE (EOL), EXHIBITING A MONITORING VOLTAGE OF 2.65V AND A CHARGE TIME OF 31 SEC. A CAPACITOR REFORM WAS PERFORMED, AND THE CHARGE TIME DROPPED TO 30.4 SECONDS. THIS DEVICE HAD BEEN IN SERVICE FOR 2.5 YEARS. A GUIDANT TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED EXPLANTING AND RETURNING THE DEVICE TO GUIDANT FOR ANALYSIS. TO DATE, THERE HAVE BEEN NO REPORTED PATIENT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY AVT | IMPLANTABLE ATRIAL GENERATOR | LWS | CARDIAC PACEMAKERS, INC | A135 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other |