FDA Adverse Event
Death
Summary report: N
PINNACLE PELVIC FLOOR REPAIR KITS
MDR report key: 2997988
·
Received March 11, 2013
Report
- Report Number
- 3005099803-2013-01169
- Event Type
- Death
- Date Received
- March 11, 2013
- Report Date
- February 14, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K071957
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WAS IMPLANTED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED AN UNKNOWN INJURY AND THE PATIENT EXPIRED. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WAS IMPLANTED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED AN UNKNOWN INJURY AND THE PATIENT EXPIRED. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102220 | PINNACLE PELVIC FLOOR REPAIR KITS | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068317100 | 0ML9091601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |