FDA Adverse Event
Malfunction
Summary report: N
700 LGX MS PUMP
MDR report key: 1503957
·
Received October 7, 2009
Report
- Report Number
- 1503957
- Event Type
- Malfunction
- Date Received
- October 7, 2009
- Date of Event
- April 29, 2009
- Report Date
- October 7, 2009
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC
- Product Code
- FHW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT EXPERIENCED A FAILED PENILE IMPLANT RESERVOIR LAST YEAR, BUT WAS FIXED BY PHYSICIAN. PATIENT RETURNED FIVE MONTHS LATER (FOLLOWING THE FIX) WITH IMPLANT CONTINUING TO MALFUNCTION. DETERMINED BY COMPANY REP TO BE DEFECTIVE AND REPLACED.
Description of Event or Problem · 1
PATIENT EXPERIENCED A FAILED PENILE IMPLANT RESERVOIR LAST YEAR, BUT WAS FIXED BY PHYSICIAN. PATIENT RETURNED FIVE MONTHS LATER (FOLLOWING THE FIX) WITH IMPLANT CONTINUING TO MALFUNCTION. DETERMINED BY COMPANY REP TO BE DEFECTIVE AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 700 LGX MS PUMP | PENILE IMPLANT | FHW | AMERICAN MEDICAL SYSTEMS, INC | IZ528467 | 578428003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | NO OTHER THERAPIES| NO OTHER THERAPIES |