MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-13 for AMS SPHINCTER 800 URINARY PROSTHESIS. AUS 72400160 manufactured by American Medical Systems, Inc..
[2198587]
On (b)(6) 2010, an aus device was implanted. On (b)(6) 2011, information was received that indicated the patient needed a revision surgery due to a device malfunction. A surgery occurred on (b)(6) 2011 that indicated an accessory kit was used, no components indicated. Additional information was received on (b)(6) 2011 that indicated the physician reported the cuff was not in the correct position and he requested an accessory kit to use to reposition the cuff. On (b)(6) 2011, an aus device was returned to ams for this patient. Additional information was requested on the reason for the removal. On (b)(6) 2011, it was indicated that on (b)(6) 2011, the physician removed the entire aus device due to "extrusion of the cuff into the urethra. "
Patient Sequence No: 1, Text Type: D, B5
[9350613]
Catalog #: 72400024, 72400098. Serial number #: (b)(4). The cuff, balloon, and pump were returned and analyzed. A leak in the cuff was noted due to operating room damage, the pump was rated as performing within specifications. The balloon was rated functional, the balloon pressure was indicated to be above specification; this may have contributed to the reported event. Should additional information become available regarding this event, it will be reevaluated and a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2011-00337 |
| MDR Report Key | 2251350 |
| Report Source | 05 |
| Date Received | 2011-09-13 |
| Date of Report | 2011-02-07 |
| Date of Event | 2011-04-06 |
| Date Mfgr Received | 2011-02-07 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2011-09-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JON CORNELL, SR. MANAGER |
| Manufacturer Street | 10700 BREN RD. WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306670 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS SPHINCTER 800 URINARY PROSTHESIS. |
| Generic Name | ARTHFICIAL URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2011-09-13 |
| Returned To Mfg | 2011-06-27 |
| Model Number | AUS |
| Catalog Number | 72400160 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-09-13 |