MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-06-21 for AMS ACTICON NEOSPHINCTER manufactured by American Medical Systems (mn).
[15588988]
It was reported the patient had her artificial bowel sphincter revised due to fluid loss. During the revision surgery, it was noted that the cuff had twisted and was torn. No patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
[24104362]
Additional information: lot/serial number: cuff (b)(4), balloon (b)(4), pump (b)(4). Catalog number: cuff 7240960, balloon 72402105, pump 72402287. Expiration date: cuff 10/10/2012, balloon 09/06/2006, pump 08/14/2007. Implant date: cuff (b)(6) 2008, balloon (b)(6) 2003, pump (b)(6) 2003. Manufacture date: cuff 10/15/2007, balloon 04/01/2007, pump 04/01/2007. Analysis results: the action (artificial bowel sphincter - abs) device was visually inspected. The cuff had a leak in the face that was due to wear at a fold. The pump and balloon performed within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2015-00263 |
| MDR Report Key | 4858263 |
| Report Source | 01,05 |
| Date Received | 2015-06-21 |
| Date of Report | 2015-05-24 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-06-23 |
| Date Added to Maude | 2015-06-21 |
| 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 | 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 | 2015-06-21 |
| Returned To Mfg | 2015-06-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-06-21 |