FDA Adverse Event
Injury
Summary report: N
VITALITY 2 VR
MDR report key: 1115151
·
Received August 14, 2008
Report
- Report Number
- 2124215-2008-35094
- Event Type
- Injury
- Date Received
- August 14, 2008
- Date of Event
- October 12, 2004
- Report Date
- June 2, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Adverse Event
- Yes
- 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 2 VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T175 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | THE DEVICE 4055/405326 WAS IMPLANTED 08-FEB-2002| THE DEVICE 4054/428380 WAS IMPLANTED 08-FEB-2002| THE DEVICE E030/500218 WAS IMPLANTED 02-JUN-2008| THE DEVICE 0185/107575 WAS IMPLANTED 12-OCT-2004| THE DEVICE 1280/526022 WAS IMPLANTED 08-FEB-2002 |