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 01/14/2014

Event Type  Injury  

Event Description

It was reported that the patient had fluid loss from a "connection" of the acticon bowel sphincter device and a revision surgery occurred on (b)(6) 2014 to correct this issue.No patient complications were reported in association with this event.

Manufacturer Narrative

Cuff catalog #: 72401960; exp.Date: 01/12/2010; serial#: (b)(4); mfg date: 1/2005.Pump catalog #: 72402287; exp.Date: 03/21/2010; serial #: (b)(4); mfg date: 3/2005.Balloon catalog #: 72402105; exp.Date: 04/14/2010; serial # (b)(4); mfg date: 4/2005.

• 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: 3734876
• MDR Text Key: 16221821
• Report Number: 2183959-2014-00118
• Device Sequence Number: 1
• Product Code: MIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 04/04/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 82 YR