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

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem Incontinence (1928)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

Cuff: catalog #: 72401958, expiration date: 9/1/2014, serial #: (b)(4), manufacture date: 9/2009.Pump: catalog #: 72402287, expiration date: 8/13/2013, serial #: (b)(4), manufacture date: 8/2012.Balloon: catalog #: 72402106, expiration date: 9/9/2015, serial #: (b)(4), manufacture date: 9/2010.The explanted acticon device was visually inspected.There was a leak in the cuff pillow that was the result of wear at a fold.The pump and balloon were not functionally tested due to the cuff leak.

Event Description

It was reported the patient had her acticon removed and replaced because of fecal incontinence due to "current device failure and leaking".No additional patient complications were reported in relation to this event.

• 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: 4989732
• MDR Text Key: 22487477
• Report Number: 2183959-2015-00345
• 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
• Report Date: 07/27/2015

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• 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: 76 YR