FDA Adverse Event
Death
Summary report: N
AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
MDR report key: 5052966
·
Received September 3, 2015
Report
- Report Number
- 2183959-2014-45284
- Event Type
- Death
- Date Received
- September 3, 2015
- Date of Event
- September 7, 2010
- Report Date
- July 30, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTP
- PMA / PMN Number
- K082730
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED (B)(6) 2014 UNDER (B)(4). LAWYER-FILED REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED EROSION, URINARY PROBLEMS, BOWEL PROBLEMS, DYSPAREUNIA, EMOTIONAL DISTRESS, AND A PRODUCT PROBLEM. IT WAS ALSO REPORTED THAT THE PLAINTIFF EXPERIENCED PELVIC PAIN, PRESSURE, AND TINGLING SENSATION. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH REPORTED WERE CARDIO RESPIRATORY FAILURE AND ASTHMA ATTACK. RELATED TO MANUFACTURER REPORT #: 2183959-2014-44751.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584513 | AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | MESH, SURGICAL, POLYMERIC | OTP | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death | MINIARC| UPHOLD| MINIARC |