MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-04-02 for AMS ACTICON NEOSPHINCTER 72401962 manufactured by Boston Scientific - Minnetonka.
[104027195]
Date of event: 2017. Catalog # (b)(4), serial# (b)(4), expiration date (b)(6) 2008, (b)(6) 2003 ; catalog # (b)(4), serial# (b)(4), expiration date (b)(6) 2008, (b)(6) 2003.
Patient Sequence No: 1, Text Type: N, H10
[104027196]
It was reported the patient had her artificial bowel sphincter removed due to a small bowel obstruction. The patient also indicated that she had "changes in bowel habits" after the implant surgery and eventually again in 2017. The three piece device was removed in three different surgeries in 2017, the cuff, then pump, then reservoir. After the third removal surgery, the patient stated she became septic. No further patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2018-00037 |
| MDR Report Key | 7387917 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-04-02 |
| Date of Report | 2018-03-08 |
| Date Mfgr Received | 2018-04-02 |
| Device Manufacturer Date | 2003-07-14 |
| Date Added to Maude | 2018-04-02 |
| 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 | 3 |
| Brand Name | AMS ACTICON NEOSPHINCTER |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | MIP |
| Date Received | 2018-04-02 |
| Catalog Number | 72401962 |
| Device Expiration Date | 2008-07-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-04-02 |