FDA Adverse Event
Malfunction
Summary report: N
VITALITY VR
MDR report key: 1043389
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33246
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 6, 2008
- Report Date
- February 6, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | 1870 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | THE DEVICE 4096/138233 WAS IMPLANTED| THE DEVICE T167/112128 WAS IMPLANTED| THE DEVICE 0158/136296 WAS IMPLANTED |