FDA Adverse Event
Injury
Summary report: N
AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
MDR report key: 4091216
·
Received September 16, 2014
Report
- Report Number
- 2183959-2014-00407
- Event Type
- Injury
- Date Received
- September 16, 2014
- Date of Event
- August 1, 2013
- Report Date
- August 20, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS (MN)
- Product Code
- OTP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RELATED TO MANUFACTURER REPORT # 2183959-2014-00404 THRU 2183959-2014-00406. IT WAS REPORTED THE PATIENT EXPERIENCED GENUINE STRESS INCONTINENCE LEAKING URINE WHILE COUGHING AND WALKING FOLLOWING THE IMPLANTATION OF AN ELEVATE PC POSTERIOR GRAFT. ANOTHER MANUFACTURER'S SLING WAS IMPLANTED ON (B)(6) 2013 WHICH RESOLVED THE EVENT.. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573403 | AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | SURGICAL MESH | OTP | AMERICAN MEDICAL SYSTEMS (MN) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | ELEVATE PC ANTERIOR |