MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS ACTICON NEOSPHINCTER; IMPLANTED FECAL INCONTINENCE DEVICE

Catalog Number SEE H10

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Cuff - catalog #: 72401958, expiration date: 03/26/2008, serial (b)(4), manufacture date: 03/2003.Balloon- catalog #: 72402104, expiration date: 07/14/2009, serial (b)(4), manufacture date: 07/2004.Pump- catalog #: 72402287, expiration date: 04/27/2011, serial (b)(4), manufacture date: 04/2006.

Event Description

It was reported that the patient was having difficulty operating their artificial bowel sphincter.The patient had always had difficulty operating the device.No patient complications reported in relation to this event.

• Brand Name: AMS ACTICON NEOSPHINCTER
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 6960798
• MDR Text Key: 90699401
• Report Number: 2183959-2017-00097
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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