FDA Adverse Event
Malfunction
Summary report: N
VITALITY DS
MDR report key: 815529
·
Received February 8, 2007
Report
- Report Number
- 2124215-2007-19000
- Event Type
- Malfunction
- Date Received
- February 8, 2007
- Date of Event
- October 17, 2006
- Report Date
- October 17, 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 BOSTON SCIENTIFIC CARDIAC RHYTHM MANAGEMENT (CRM) RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED ON AUGUST 24, 2005, HAS A CURRENT BATTERY VOLTAGE OF 2.57V. THERE IS CONCERN THAT THE DEVICE'S BATTERY IS DEPLETING QUICKER THAN EXPECTED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
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 | 54 YR | Other |