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

Device Problem Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 06/24/2014

Event Type  Injury  

Event Description

It was reported the patient had her acticon device removed and replaced due to a leak of the cuff.No patient complications were reported in relation to this event.

Manufacturer Narrative

Cuff: catalog #: 72401980, expiration date: 07/28/2013, serial #: (b)(4), manufacture date: 07/2008.Balloon: catalog #: 72402105, expiration date: 02/24/2014, serial #: (b)(4), manufacture date: 03/2009.Pump: catalog #: 72402287, expiration date: 03/09/2014, serial #: (b)(4).Manufacture date: 03/2009, the acticon device was visually inspected.There was a leak in the cuff 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: 3928370
• MDR Text Key: 18063628
• Report Number: 2183959-2014-00290
• 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: 06/25/2014

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/11/2014
• 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: 39 YR