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 Type  Injury  

Event Description

It was reported that the patient is scheduled to have his artificial bowel sphincter removed and replaced on (b)(6) 2015 due to "the pump is no longer working or there is fluid loss." no patient complications have been reported in relation to this event.

Manufacturer Narrative

(in order of cuff, pump, balloon): serial #: (b)(4).Catalog #: 72401984, 72402287, 72402106.Expiration date: 4/29/2014, 8/15/2014, 4/02/2015.(in order of cuff, pump, balloon): manufacture date: 5/01/2009, 8/20/2013, 4/15/2013.

Manufacturer Narrative

Analysis results: the aus 800 device was visually inspected.There was a leak in the cuff pillow at the fillet junction that was the result of fatigue.There was a leak in the pump-cuff tube that was the result of a sharp instrument which resembled a needle hole.The pump and balloon were not functionally tested due to the cuff 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: 4857333
• MDR Text Key: 5871878
• Report Number: 2183959-2015-00262
• 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,Followup
• Report Date: 06/12/2015

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: 07/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 06/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2015
• 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