FDA Adverse Event
Death
Summary report: N
VITALITY 2
MDR report key: 1667405
·
Received April 23, 2010
Report
- Report Number
- 2124215-2010-08864
- Event Type
- Death
- Date Received
- April 23, 2010
- Date of Event
- March 24, 2010
- Report Date
- March 24, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Removal / Correction Number
- Z-1047-2007 TO Z-1055-07
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT COULD NOT BE CONFIRMED WHETHER THIS ICD WOULD BE RETURNED TO THE BOSTON SCIENTIFIC CRM POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS PURPOSES. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY NOT HAVE PROVIDED LIFE-SAVING THERAPY. THE PATIENT'S ADVOCATE NOTED THAT THE PATIENT'S HEART HAD JUST STOPPED AND NOTED SURPRISE THAT THE DEVICE DID NOT RESPOND. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR MORE INFORMATION, BUT NONE HAS BECOME AVAILABLE TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death | 4086| 4513| 0154 |