MAUDE Adverse Event Report: AMERICAN MEDICAL CENTER AMS ACTICON NEOSPHINCTER; IMPLANTED FECAL INCONTINENCE DEVICE

Catalog Number 72402105

Device Problem Leak/Splash (1354)

Patient Problems Failure of Implant (1924); Incontinence (1928)

Event Date 06/11/2014

Event Type  Injury  

Event Description

The patient had an ams acticon bowel sphincter implanted on (b)(6) 2004.The acticon balloon was removed and replaced on (b)(6) 2014 due to recurring incontinence and fluid loss.No patient complication were reported.

Manufacturer Narrative

The acticon balloon was returned for analysis.The balloon was visually inspected and a leak in the sphere was noted that was the result of a sharp instrument.

• Brand Name: AMS ACTICON NEOSPHINCTER
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): AMERICAN MEDICAL CENTER; lazarv street 14; rishon lezion ; IS
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4045720
• MDR Text Key: 4864560
• Report Number: 2183959-2014-00381
• Device Sequence Number: 1
• Product Code: MIP
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P010020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/21/2009
• Device Catalogue Number: 72402105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR