FDA Adverse Event
Malfunction
Summary report: N
VITALITY DS
MDR report key: 1043522
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33127
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 4, 2008
- Report Date
- February 4, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
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 | 69 YR | Other | THE DEVICE 4053/415577 WAS IMPLANTED 06-MAY-2004| THE DEVICE 0158/140832 WAS IMPLANTED 06-MAY-2004 |