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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72400165
Medical Device Problem Codes Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code Incontinence (1928)
Date of Event 01/16/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient experienced recurring incontinence over the past year with a twenty one year old artificial urinary sphincter (aus).A replacement surgery was performed in which the existing device was removed and a new aus was implanted.During the procedure fluid loss was noted due to tubing from pump being torn; however, the reason for the tear was unknown.The patient did not experience any further adverse events.The patient was said to be good after the procedure.No more information available at the moment.Should additional information become available, it will be provided.
 
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Brand Name
AMS 800 URINARY CONTROL SYSTEM
Common Device Name
DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9639143
Report Number2183959-2020-00293
Device Sequence Number2784230
Product Code EZY
UDI-Device Identifier00878953000763
UDI-Public00878953000763
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P000053
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year1998
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/28/2020
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 Lay User/Patient
Device Model Number72400165
Device Catalogue Number72400165
Device Lot NumberDB289009
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/17/2020
Initial Report FDA Received Date01/28/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age51 YR
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