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

Catalog Number SEE H10

Device Problems Leak/Splash (1354); Insufficient Information (3190)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Patient Problem/Medical Problem (2688)

Event Date 03/10/2014

Event Type  Injury  

Event Description

It was reported that the patient will need her acticon replaced due to infection and inflammation.At this time, ams is not aware of any scheduled surgeries for this patient.No additional patient complications were reported in relation to this event.

Manufacturer Narrative

Cuff, catalog #: 72401960, serial #: (b)(4), expiration date: 03/12/2014.Balloon, catalog #: 72402106, serial #: (b)(4), expiration date: 02/19/2014.Pump, catalog #: 72402287, serial #: (b)(4), expiration date: 03/16/2014.Should additional information become available regarding this event it will be re-evaluated and a follow-up report will be sent.

Manufacturer Narrative

A duplicate original report was previously sent under manufacturer report number 2183959-2014-00073.The device was returned for analysis.The acticon device was visually inspected.There was a leak in the cuff that was the result of wear at a fold in the cuff.There were no leaks found in the pump or balloon.

Event Description

Additional information received indicated that the patient had her acticon device removed and replaced due to recurring incontinence from atrophy and fluid loss.No additional 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: 3620434
• MDR Text Key: 4135170
• Report Number: 2183959-2014-00014
• 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: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2014

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 Catalogue Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 02/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• 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: 67 YR