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

Device Problem Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

Cuff: catalog #: 72401980, expiration date: 4/24/2014, serial #: (b)(4), manufacture date: 4/29/2009, date implanted: (b)(6) 2010, date explanted: (b)(6) 2016.Balloon: catalog #: 72402106, expiration date: 11/19/2014, serial #: (b)(4), manufacture date: 12/3/2009, date implanted: (b)(6) 2010, date explanted: (b)(6) 2016.Pump: catalog #: 72402287, expiration date: 12/28/2014, serial #: (b)(4), manufacture date: 1/5/2010, date implanted: (b)(6) 2010, date explanted: (b)(6) 2016.

Event Description

It was reported that the patient had his acticon removed and replaced due to unspecified reasons.It was later reported that the acticon was replaced on (b)(6) 2016 due to fecal incontinence.No patient complications were reported in relation to this event.

• 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: 5602720
• MDR Text Key: 43434289
• Report Number: 2183959-2016-00108
• 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: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• 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: 50 YR