FDA Adverse Event
Death
Summary report: N
VITALITY 2 DR
MDR report key: 1201767
·
Received October 16, 2008
Report
- Report Number
- 2124215-2008-99953
- Event Type
- Death
- Date Received
- October 16, 2008
- Date of Event
- February 24, 2008
- Report Date
- October 17, 2008
- Manufacturer
- CLONMEL
- Product Code
- LWS
- Removal / Correction Number
- Z47/55-07
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE WAS NOT RETURNED FOR ANALYSIS, AND IT IS BELIEVED THAT IT WAS BURIED WITH THE PT. ATTEMPTS TO OBTAIN ADDITIONAL INFO WERE UNSUCCESSFUL. AT THIS TIME, NO ADDITIONAL INFO IS AVAILABLE. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THE PT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPIRED, DUE TO LONG TERM HEART FAILURE. THE PT'S SPOUSE REPORTED THAT THIS DEVICE WAS NOT WORKING PROPERLY, HOWEVER, NO DETAILS OF THE DEVICE ISSUE WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CLONMEL | T165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | 0185| 4087 |