FDA Adverse Event
Injury
Summary report: N
VITALITY AVT FAST-CHARGE
MDR report key: 1041811
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34830
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 7, 2008
- Report Date
- March 7, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY AVT FAST-CHARGE | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | A155 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | THE DEVICE 0158/130878 WAS IMPLANTED 12-FEB-2004| THE DEVICE T165/139818 WAS IMPLANTED 07-MAR-2008| THE DEVICE 4470/373543 WAS IMPLANTED 12-FEB-2004 |