FDA Adverse Event
Malfunction
Summary report: N
VITALITY DR
MDR report key: 1041794
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34841
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 25, 2008
- Report Date
- March 25, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | 1871 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other | THE DEVICE 0158/146381 WAS IMPLANTED 04-OCT-2004| THE DEVICE 4087/172034 WAS IMPLANTED 04-OCT-2004 |