FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 DR
MDR report key: 711106
·
Received May 9, 2006
Report
- Report Number
- 2124215-2006-13231
- Event Type
- Malfunction
- Date Received
- May 9, 2006
- Date of Event
- January 18, 2006
- Report Date
- January 18, 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) EXHIBITED A MONITORING VOLTAGE OF 2.59 VOLTS WHILE STILL IN THE BOX. THE BOX LABEL SHOWED THAT THE MONITORING VOLTAGE SHOULD BE 3.25 VOLTS. THE DECISION WAS MADE TO NOT IMPLANT THIS DEVICE, BUT TO RETURN IT 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 2 DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T165 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |