FDA Adverse Event
Injury
Summary report: N
VITALITY DR HE
MDR report key: 1043015
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33628
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- February 18, 2008
- Report Date
- February 18, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/55-07
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY DR HE | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T180 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | THE DEVICE 0185/144510 WAS IMPLANTED 09-JUN-2006| THE DEVICE T175/132884 WAS IMPLANTED 18-FEB-2008 |