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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 05/08/2015

Event Type  Injury  

Event Description

It was reported that the patient had his action neosphincter removed and replaced due to fluid loss, "cuff." there were no patient complications reported as a result of this event.

Manufacturer Narrative

(in order of cuff, pump, balloon): catalog #: 72401964, 72402287, 72402104; expiration date: 12/15/2015, 04/05/2014, 12/12/2017; serial #: (b)(4).(in order of cuff, pump, balloon): manufacture date: 6/26/2012, 04/09/2013, 01/02/2013.

Manufacturer Narrative

Device evaluation: the acticon device was visually inspected.There was a leak in the cuff at the face/backing junction that was due to fatigue.The pump and balloon were not tested due to the leak.

• 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: 4810950
• MDR Text Key: 5922578
• Report Number: 2183959-2015-00218
• Device Sequence Number: 1
• Product Code: MIP
• Combination Product (y/n): N
• PMA/PMN Number: P010020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2015

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: 06/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• 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: 67 YR