FDA Adverse Event
Injury
Summary report: N
VITALITY 2 DR
MDR report key: 816460
·
Received February 8, 2007
Report
- Report Number
- 2124215-2007-18632
- Event Type
- Injury
- Date Received
- February 8, 2007
- Date of Event
- September 1, 2006
- Report Date
- October 25, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z1288/92-6
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION BOSTON SCIENTIFIC (FORMALLY GUIDANT CORP) RECEIVED INFORMATION THAT A DEVICE MEMORY DISK IS ENROUTE FOR ANALYSIS IN RESPONSE TO A RECENT SAFETY COMMUNICATION THAT WAS ISSUED ON MAY 12, 2006 FOR THIS DEVICE MODEL. A DISK WAS RETURNED BUT WAS NOT READABLE. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT.
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 | 58 YR | Required Intervention |