MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-19 for AMS ACTICON NEOSPHINCTER SEE H10 manufactured by Boston Scientific - Minnetonka.
[90699401]
Cuff - catalog #: 72401958, expiration date: 03/26/2008, serial (b)(4), manufacture date: 03/2003. Balloon- catalog #: 72402104, expiration date: 07/14/2009, serial (b)(4), manufacture date: 07/2004. Pump- catalog #: 72402287, expiration date: 04/27/2011, serial (b)(4), manufacture date: 04/2006.
Patient Sequence No: 1, Text Type: N, H10
[90699402]
It was reported that the patient was having difficulty operating their artificial bowel sphincter. The patient had always had difficulty operating the device. No patient complications reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2017-00097 |
| MDR Report Key | 6960798 |
| Date Received | 2017-10-19 |
| Date of Report | 2017-10-16 |
| Date Mfgr Received | 2017-10-16 |
| Date Added to Maude | 2017-10-19 |
| 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 | 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 | BOSTON SCIENTIFIC - MINNETONKA |
| 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 | 0 |
| Brand Name | AMS ACTICON NEOSPHINCTER |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | MIP |
| Date Received | 2017-10-19 |
| Catalog Number | SEE H10 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MINNETONKA |
| Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-19 |