FDA Adverse Event
Malfunction
Summary report: N
VITALITY DS
MDR report key: 711531
·
Received May 9, 2006
Report
- Report Number
- 2124215-2006-13696
- Event Type
- Malfunction
- Date Received
- May 9, 2006
- Date of Event
- February 15, 2006
- Report Date
- February 15, 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 APRIL 25, 2005, DISPLAYED A BATTERY STATUS OF MIDDLE-OF-LIFE 2 (MOL2) AND A MONITORING VOLTAGE OF 2.71V UPON INTERROGATION. THE PATIENT HAS HAD ANTITACHYCARDIA PACING (ATP) AND A COUPLE OF SHOCKS. HOWEVER, THERE IS CONCERN THAT THE BATTERY ON THIS ICD IS DEPLETING TOO QUICKLY. THE DECISION WAS MADE TO EXPLANT THIS DEVICE, AND TO RETURN IT TO GUIDANT FOR ANALYSIS. A SIMILAR DEVICE WAS IMPLANTED WITHOUT REPORTED COMPLICATION.
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 | 76 YR | Other |