FDA Adverse Event
Injury
Summary report: N
PINNACLE PELVIC FLOOR REPAIR KIT
MDR report key: 1122760
·
Received August 18, 2008
Report
- Report Number
- 3005099803-2008-02851
- Event Type
- Injury
- Date Received
- August 18, 2008
- Date of Event
- July 15, 2008
- Report Date
- July 21, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FTM
- PMA / PMN Number
- K071957
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT THE PT EXPERIENCED BUTTOCK PAIN THE DAY AFTER A PELVIC FLOOR REPAIR PROCEDURE USING THE PINNACLE PFR KIT. THE PT'S PAIN INITIALLY IMPROVED, BUT SHE LATER EXPERIENCED SIGNIFICANT PAIN IN HER BUTTOCK AND RIGHT LEG, MAKING IT VERY DIFFICULT FOR HER TO STAND ON HER RIGHT LEG. SHE IS UNDER THE CARE OF A PHYSICAL THERAPIST TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINNACLE PELVIC FLOOR REPAIR KIT | FTM | BOSTON SCIENTIFIC CORPORATION | M0068317050 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |