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

Catalog Number 72401978

Device Problems Device Operates Differently Than Expected (2913); Failure of Device to Self-Test (2937); Insufficient Information (3190)

Patient Problems Incontinence (1928); Constipation (3274)

Event Date 01/24/2014

Event Type  Injury  

Event Description

It was reported that the patient had her acticon cuff removed and replaced on (b)(6) 2014 due to recurring incontinence.The acticon cuff had come undone due to constipation issues.No additional patient complications were reported in relation to this event.

Event Description

Additional information received indicated that there was a "malfunction of the cuff portion of the artificial bowel sphincter".It was also indicated that "repeat sizing was carried out, number 10 size was correct and the cuff was replaced".

Manufacturer Narrative

Should additional information become available regarding this event it will be re-evaluated and a follow-up report will be sent.

Manufacturer Narrative

The acticon device returned for evaluation on (b)(6) 2014.Analysis results indicate there was a tear in the backing at the buttonhole which may have contributed to cuff becoming "undone.".

• 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: 3604619
• MDR Text Key: 4177729
• Report Number: 2183959-2014-00010
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2014

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
• Device Expiration Date: 01/04/2016
• Device Catalogue Number: 72401978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 02/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/22/2014; 06/30/2014; 08/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 104