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 Failure of Implant (1924)

Event Date 05/26/2015

Event Type  Injury  

Event Description

It was reported the patient had his acticon removed and replaced due to fluid loss, non-functioning.No patient complications were reported in relation to this event.

Manufacturer Narrative

Cuff: catalog #: 72401962, expiration date: 12/28/2008, serial #: (b)(4).Manufacture date: 12/2003.Pump: catalog #: 72402287, expiration date: 3/17/2009, serial #: (b)(4), manufacture date: 3/2004.Balloon: catalog #: 72402105, expiration date: 1/12/2009, serial #: (b)(4), manufacture date: 1/2004.The acticon device was visually inspected.There was a leak in the cuff pillow that was the 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: 4835018
• MDR Text Key: 5944142
• Report Number: 2183959-2015-00234
• 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: 05/27/2015

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/10/2015
• 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: 58 YR