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

Catalog Number SEE H10

Device Problem Material Erosion (1214)

Event Date 12/10/2013

Event Type  Injury  

Event Description

It was reported the patient experienced erosion and fluid loss of their acticon bowel sphincter.The device was explanted on (b)(6) 2013 and not replaced.No further patient complications were reported in relation of this event.

Manufacturer Narrative

Additional device info: cuff- catalog #: 72401978; serial # (b)(4); expiration date 08/29/2006.Balloon- catalog #: 72402105; serial # (b)(4); expiration date 12/01/2009.Pump- catalog #: 72402287; serial # (b)(4); expiration date 01/06/2010.Device was visually inspected.A leak was found in the cuff.The leak in the cuff is from wear at the inside of a fold in the face of the cuff.

• 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: 3620889
• MDR Text Key: 20973179
• Report Number: 2183959-2014-00016
• Device Sequence Number: 1
• Product Code: MIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 01/09/2014

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
• Device Catalogue Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• 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: 60 YR