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

Catalog Number 72401958

Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 11/04/2014

Event Type  Injury  

Event Description

It was reported the patient had her acticon system replaced due to recurring incontinence.No further patient complications were reported in relation to this event.

Event Description

Additional information received indicated the device was also removed due to fluid loss.

Manufacturer Narrative

Balloon: model# 72402105, serial # (b)(4), expiration date 4/16/2015, manufacturer date 04/2010.Pump: model# 72402287, serial # (b)(4), expiration date 6/3/2015, manufacturer date 06/2010.

Manufacturer Narrative

Analysis results the action device was visually inspected.There was a leak in the cuff pillow that was the result of wear at a fold.The pump and balloon were not functionally tested due to the cuff leak.

• 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: 4409357
• MDR Text Key: 5304664
• Report Number: 2183959-2015-00008
• Device Sequence Number: 1
• Product Code: MIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/24/2014
• Device Catalogue Number: 72401958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2009
• 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: 54 YR