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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 UNK-P-SLING-MENS_ADVANCE_XP
Device Problem Insufficient Information (3190)
Patient Problem Incontinence (1928)
Event Date 08/26/2020
Event Type  Injury  
Event Description

It was reported that the patient had an advance xp sling implanted in 2015. The patient's level of incontinence following sling procedure was unchanged. The artificial urinary sphincter was implanted due to complete incontinence resulting in the patient using a condom catheter. A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted due to unspecified reasons. The aus will be activated six weeks following implantation.

 
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Brand NameAMS ADVANCE XP SLING SYSTEM
Type of DeviceMESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752 1242
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 Key10475101
MDR Text Key205086831
Report Number2183959-2020-03876
Device Sequence Number1
Product Code OTM
Combination Product (Y/N)N
Reporter Country CodeHR
PMA/PMN NumberK182169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberUNK-P-SLING-MENS_ADVANCE_XP
Device Catalogue NumberUNK-P-SLING-MENS_ADVANCE_XP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/31/2020 Patient Sequence Number: 1
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