FDA Adverse Event
Malfunction
Summary report: N
VITALITY+ DR
MDR report key: 1043596
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33060
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- January 30, 2008
- Report Date
- January 30, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY+ DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | 1872 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | THE DEVICE 0125/221587 WAS IMPLANTED 11-NOV-1997| THE DEVICE 1821/200282 WAS IMPLANTED 11-NOV-1997| THE DEVICE T165/139537 WAS IMPLANTED |