FDA Adverse Event
Death
Summary report: N
VITALITY 2 DR
MDR report key: 944905
·
Received November 8, 2007
Report
- Report Number
- 2124215-2007-25777
- Event Type
- Death
- Date Received
- November 8, 2007
- Date of Event
- August 15, 2005
- Report Date
- September 19, 2007
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
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 | 74 YR | Death |