MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-08-11 for AMS ACTICON NEOSPHINCTER manufactured by American Medical Systems (mn).
[22487477]
Cuff: catalog #: 72401958, expiration date: 9/1/2014, serial #: (b)(4), manufacture date: 9/2009. Pump: catalog #: 72402287, expiration date: 8/13/2013, serial #: (b)(4), manufacture date: 8/2012. Balloon: catalog #: 72402106, expiration date: 9/9/2015, serial #: (b)(4), manufacture date: 9/2010. The explanted acticon device was visually inspected. There was a leak in the cuff pillow that was the result of wear at a fold. The pump and balloon were not functionally tested due to the cuff leak.
Patient Sequence No: 1, Text Type: N, H10
[22487478]
It was reported the patient had her acticon removed and replaced because of fecal incontinence due to "current device failure and leaking". No additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2015-00345 |
| MDR Report Key | 4989732 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-08-11 |
| Date of Report | 2015-07-27 |
| Date of Event | 2015-07-27 |
| Date Mfgr Received | 2015-07-27 |
| Date Added to Maude | 2015-08-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SHARON ZURN |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306000 |
| Manufacturer G1 | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS ACTICON NEOSPHINCTER |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | MIP |
| Date Received | 2015-08-11 |
| Returned To Mfg | 2015-08-05 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-08-11 |