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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM ACCESSORY KIT (US); DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM ACCESSORY KIT (US); DEVICE INCONTINENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 720066-01
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code Urinary Incontinence (4572)
Date of Event 03/23/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgical procedure to revise this artificial urinary sphincter (aus) due to the cuff not functioning as a result of a connector issue causing the patients incontinence to return.The aus remains implanted and active and the cuff connector was adjusted.There were no patient complications and the cuff was functioning following activation.
 
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Brand Name
AMS 800 URINARY CONTROL SYSTEM ACCESSORY KIT (US)
Common Device Name
DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11677654
Report Number2124215-2021-08790
Device Sequence Number3149784
Product Code EZY
UDI-Device Identifier00878953004938
UDI-Public00878953004938
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/16/2021
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
Operator of Device Health Professional
Device Expiration Date10/19/2025
Device Model Number720066-01
Device Catalogue Number720066-01
Device Lot Number1000476055
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/23/2021
Initial Report FDA Received Date04/16/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age65 YR
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