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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2015

Event Type  Injury  

Event Description

It was reported the patient had her artificial bowel sphincter revised due to fluid loss.During the revision surgery, it was noted that the cuff had twisted and was torn.No patient complications were reported in relation to this event.

Manufacturer Narrative

Additional information: lot/serial number: cuff (b)(4), balloon (b)(4), pump (b)(4).Catalog number: cuff 7240960, balloon 72402105, pump 72402287.Expiration date: cuff 10/10/2012, balloon 09/06/2006, pump 08/14/2007.Implant date: cuff (b)(6) 2008, balloon (b)(6) 2003, pump (b)(6) 2003.Manufacture date: cuff 10/15/2007, balloon 04/01/2007, pump 04/01/2007.Analysis results: the action (artificial bowel sphincter - abs) device was visually inspected.The cuff had a leak in the face that was due to wear at a fold.The pump and balloon performed within specifications.

• 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: 4858263
• MDR Text Key: 15588988
• Report Number: 2183959-2015-00263
• Device Sequence Number: 1
• Product Code: MIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/24/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 06/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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