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

Catalog Number 72401956

Device Problem Fluid/Blood Leak (1250)

Patient Problem Incontinence (1928)

Event Date 01/06/2015

Event Type  Injury  

Event Description

It was reported that the patient's acticon neosphincter was removed because of fluid loss and "return to fecal incontinence".No additional patient complications were reported in relation to this event.

Manufacturer Narrative

Additional components: pump catalog number: 72402287, serial number: (b)(4), manufacture date: 07/25/2006, expiration date: 07/20/2011.Balloon catalog number: 72402106, serial number: (b)(4), manufacture date: 06/30/2006, expiration date: 07/20/2011.Evaluation summary: the acticon device was visually inspected.There was a leak in the cuff pillow that was the result of fatigue and wear at a fold.The pump and balloon were not functionally tested due to the cuff leak.There was a leak in the cuff tube that was the result of tool damage which probably occurred during removal.

• 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: 4444540
• MDR Text Key: 5315347
• Report Number: 2183959-2015-00031
• 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: 01/12/2015

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
• Device Expiration Date: 07/21/2009
• Device Catalogue Number: 72401956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2004
• 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: 55 YR