MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number 720157-01

Device Problem Fluid/Blood Leak (1250)

Patient Problem Incontinence (1928)

Event Date 02/06/2020

Event Type  Injury  

Event Description

It was reported that the patient had the ams 800 artificial urinary sphincter (aus) removed as there was no fluid in it due a leak from undetermined location.A new artificial urinary sphincter consisting of a cuff, pump, and balloon were implanted.Additional information received indicated that the patient experienced recurring incontinence.The patient status post procedure was good.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• Type of Device: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 9772550
• MDR Text Key: 181486635
• Report Number: 2183959-2020-00970
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953005652
• UDI-Public: 00878953005652
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2015
• Device Model Number: 720157-01
• Device Catalogue Number: 720157-01
• Device Lot Number: 915474010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALLOON LOT 935996013; PUMP LOT 933096012
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR