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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 72400164
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/10/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgical procedure to reimplant this artificial urinary sphincter (aus) device due to fluid loss.The aus cuff, pump, and balloon was explanted in 2019 and no new device was implanted.On (b)(6) 2020 a new aus cuff, pump, and balloon was implanted.The patient was stable following the procedure.
 
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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 Key11165469
Report Number2183959-2020-06371
Device Sequence Number677065
Product Code EZY
UDI-Device Identifier00878953000756
UDI-Public00878953000756
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
P000053
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/13/2021
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 Lay User/Patient
Device Expiration Date05/28/2023
Device Model Number72400164
Device Catalogue Number72400164
Device Lot Number1000112872
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/23/2020
Initial Report FDA Received Date01/13/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age58 YR
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