FDA Adverse Event
Malfunction
Summary report: N
VITALITY AVT
MDR report key: 815397
·
Received February 8, 2007
Report
- Report Number
- 2124215-2007-19708
- Event Type
- Malfunction
- Date Received
- February 8, 2007
- Date of Event
- November 16, 2006
- Report Date
- November 16, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z1107-9/05
- 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 RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED AN ELECTIVE REPLACEMENT INDICATOR (ERI). THERE IS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. THE MONITORING VOLTAGE WAS 2.69V WITH A CHARGE TIME OF 26.9 SECONDS. THIS DEVICE IS PART OF THE AVT LATCHING POPULATION (6/17/2005).
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 | 59 YR | Other |