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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Incontinence (1928)

Event Date 06/30/2015

Event Type  Injury  

Event Description

It was reported the patient had her acticon balloon and pump removed and replaced due to incontinence.It was indicated that there was blood found in the balloon, there was not fluid loss, and "they are not defected".No additional patient complications were reported in relation to this event.

Manufacturer Narrative

Cuff: catalog #: 72401964, expiration date: 08/13/2017, serial #: (b)(4), manufacture date: 06/2011.Balloon: catalog #: 72402104, expiration date: 3/25/2018, serial #: (b)(4), manufacture date: 04/2013.Pump: catalog #: 72402287, expiration date: 04/25/2015, serial #: (b)(4), manufacture date: 05/2014.

Manufacturer Narrative

Updated data: the explanted aus 800 device was visually inspected and functionally tested.No leak was found.The pump was not functionally tested due to blood inside pump.The balloon pressure tested at 57.5 cmh2o.It was originally rated at 81-90 cmh2o.The balloon was returned with blood inside.

• 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: 4919394
• MDR Text Key: 6434840
• Report Number: 2183959-2015-00308
• Device Sequence Number: 1
• Product Code: MIP
• Combination Product (y/n): N
• PMA/PMN Number: P010020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• 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: 65 YR