FDA Adverse Event
Death
Summary report: N
FINELINE II
MDR report key: 1660992
·
Received April 15, 2010
Report
- Report Number
- 2124215-2010-08081
- Event Type
- Death
- Date Received
- April 15, 2010
- Date of Event
- March 24, 2010
- Report Date
- March 23, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT IS UNK IF THE LEAD WAS REMOVED POST MORTEM. SHOULD ADD'L INFO BECOME AVAILABLE, OR SHOULD THIS LEAD GET RETURNED, THIS EVENT WOULD BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFO FROM A PT INFO VERIFICATION FORM FILLED OUT BY THE PT'S SPOUSE. THE FORM STATED, THE PT PASSED AWAY THREE DAYS LATER AND ALLEGED CONCERN WITH DEVICE INVOLVEMENT. THE BOSTON SCIENTIFIC FIELD REP WAS NOTIFIED, CONTACTED THE PHYSICIAN, AND WAS TOLD CAUSE OF DEATH WAS UNK, HOWEVER, THERE WERE NO ALLEGATIONS AGAINST ANY OF THE PT'S IMPLANTED PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death | 4469, MISMATCH |