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

Catalog Number SEE H10

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 01/24/2014

Event Type  Injury  

Event Description

It was reported the patient had her acticon device revised on (b)(6) 2014 due to infection of the "peri-balloon" and erosion.It was reported that the "right labia pump tubing" was "visible" and the "physician found pus in and around the different pockets".No additional patient complications were reported in relation to this event.

Manufacturer Narrative

Additional information: the acticon device was visually inspected and functionally tested.There was a leak in the cuff that was the result of tool damage which probably occurred during removal.The balloon and pump were both analyzed and tested ou of specification.This was unrelated to the reported event of erosion and infection.

Manufacturer Narrative

Pump: catalog #: 72402287, serial #: (b)(4), expiration date: 11/09/2014, manufacture date: 11/2009.Balloon: catalog #: 72402106.Serial #: (b)(4), expiration date: 09/09/2013, manufacture date: 09/2008.Cuff: catalog #: 72401962, serial #: (b)(4), expiration date: 09/04/2013, manufacture date: 09/2008.Should additional information become available regarding this event it will be re-evaluated and a follow-up report will be sent.

• 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: 3610466
• MDR Text Key: 4064390
• Report Number: 2183959-2014-00017
• 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: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2014
• 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: 48 YR