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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
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BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number 720163-01
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Incontinence (1928)
Date of Event 10/12/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient had an advance xp sling implanted.Following the implant surgery the patient's incontinence improved but he still continued to experience some urinary incontinence.It is not believed that there were any device issues or malfunctions that contributed to the continued incontinence.The patient was then implanted with an artificial urinary sphincter (aus) device.
 
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Brand Name
AMS ADVANCE XP SLING SYSTEM
Common Device Name
MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752 1242
MDR Report Key10817827
Report Number2183959-2020-05409
Device Sequence Number11806591
Product Code OTM
UDI-Device Identifier00878953005560
UDI-Public00878953005560
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/10/2020
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? No
Operator of Device Lay User/Patient
Device Expiration Date07/23/2020
Device Model Number720163-01
Device Catalogue Number720163-01
Device Lot Number0024311564
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/15/2020
Initial Report FDA Received Date11/10/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age59 YR
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