FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 DR
MDR report key: 710786
·
Received May 9, 2006
Report
- Report Number
- 2124215-2006-13809
- Event Type
- Malfunction
- Date Received
- May 9, 2006
- Date of Event
- February 21, 2006
- Report Date
- February 21, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A MONITORING VOLTAGE OF 2.59V. THE VOLTAGE AT LAST FOLLOWUP 3 MONTHS AGO WAS 2.94V. THE PACING OUTPUT IS 2.6V AT .4MS IN BOTH CHAMBERS. THE PATIENT IS 55% ATRIAL PACED AND LESS THAN 1% VENTRICULAR PACED. THERE HAS BEEN NO SHOCK THERAPY. THE CHARGE TIME IS 8.4 SECONDS AND ALL IMPEDANCES ARE STABLE. THERE IS NO HISTORY OF PROLONGED MAGNET APPLICATION.
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 | 72 YR | Other |