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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Micturition Urgency (1871); Internal Organ Perforation (1987); Urinary Tract Infection (2120); Urinary Frequency (2275)

Event Date 02/20/2015

Event Type  Injury  

Event Description

It was reported that the patient presented with urinary urgency and frequency and a urinary tract infection.A surgery was performed and the balloon for the acticon bowel sphincter had perforated the bladder.The entire acticon device was removed.There were no further patient complications reported as a result of this event and the patient was "fine" following the surgery.

Manufacturer Narrative

Information below in order of cuff, balloon, pump: catalog #: 72401956, 72402106, 72402287; expiration date: 11/13/2017, 4/2/2018, 12/12/2015; serial #: 801389001, 823978003, 911102006; other # (udi for the pump only): (b)(4).Device manufacture date: 11/2012, 4/2013, 12/2014.

• 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: 4601448
• MDR Text Key: 18002703
• Report Number: 2183959-2015-00091
• 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: 02/20/2015

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: 02/20/2015
• Initial Date FDA Received: 03/13/2015
• 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: 55 YR