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

Device Problem Malposition of Device (2616)

Patient Problems Fistula (1862); Pain (1994)

Event Type  Injury  

Event Description

It was reported by the patient that she is unhappy with the placement of her acticon balloon because of "scar tissue/fistula" in the area causing "pain/discomfort".No additional patient complications were reported in relation to this event.

Manufacturer Narrative

Cuff: catalog #: 72401980, expiration date: 1/15/2015, serial #: (b)(4), manufacture date: 1/2010, implant date: (b)(6) 2013.Pump: implant date: 2008, balloon: catalog #: 72402105, expiration date: 07/12/2017, serial #: (b)(4), manufacture date: 07/2012, implant date: (b)(6) 2013.

• 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: 4079545
• MDR Text Key: 4895131
• Report Number: 2183959-2014-00396
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2014

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2014
• Initial Date FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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