MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ACTICON NEOSPHINCTER; IMPLANTED FECAL INCONTINENCE DEVICE

Catalog Number SEE H10

Device Problem Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 03/31/2004

Event Type  Injury  

Event Description

It was reported that the patient had her acticon device replaced due to "malfunction - hole in system - pump stopped working".No patient complications were reported in relation to this event.The patient was then implanted with another manufacturer's fecal incontinence device.

Manufacturer Narrative

Cuff catalog #: 72401962; exp.Date: 8/25/2008; serial#: (b)(4); mfg date: 8/2003; implanted (b)(6) 2005.Pump catalog #: 72402287; exp.Date: 5/17/2012; serial #: (b)(6); mfg date: (b)(6) 2007; implanted (b)(6) 2007.Balloon catalog #: 72402106; exp.Date: 3/29/2012; serial # (b)(6); mfg date: 3/2007; implanted (b)(6) 2007; the device was returned for evaluation - analysis results indicate the cuff exhibited a leak that was a result of wear at a fold.

• Brand Name: AMS ACTICON NEOSPHINCTER
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• 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: 3751070
• MDR Text Key: 4420287
• Report Number: 2183959-2014-00122
• Device Sequence Number: 1
• Product Code: MIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2014

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 33 YR