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

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Incontinence (1928)

Event Date 06/30/2014

Event Type  Injury  

Event Description

It was reported that a patient with an acticon device is experiencing fecal incontinence after an automobile accident.An initial surgery occurred on (b)(6) 2014 to confirm that the device is no longer working.The acticon device will be removed and replaced in an upcoming surgery.No additional patient complications were reported in relation to this event.

Event Description

It was reported that the acticon device was removed and replaced on (b)(6) 2014 due to fluid loss.No additional patient complications were reported in relation to this event.

Manufacturer Narrative

Cuff: catalog #: 72401982; expiration date: 04/28/2014; serial #: (b)(4).Implant date: (b)(6) 2010; manufacture date: 04/2009.Balloon: catalog #: 72402106; expiration date: 03/10/2014; serial #: (b)(4); implant date: (b)(6) 2009; manufacture date: 3/2009.Pump: catalog #: 72402287; expiration date: 3/16/2014; serial #: (b)(4); implant date: (b)(6) 2009; manufacture date: 3/2009.

Manufacturer Narrative

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.

• 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: 3920253
• MDR Text Key: 4520006
• Report Number: 2183959-2014-00283
• 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: 06/11/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2014
• Initial Date FDA Received: 07/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2014
• 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: 36 YR