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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 Mechanical Problem (1384)
Health Effect - Clinical Code Incontinence (1928)
Date of Event 12/26/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient began experiencing recurrence of his incontinence after being implanted with an advance xp sling device.Following implantation of the sling the patient's incontinence was better than baseline during the first week.Then, starting on (b)(6) 2019, the patient began experiencing increasing stress incontinence back to the same level as prior to having the sling device implanted.It is believed that there may have been a displacement of the sling.There were no further complications reported.
 
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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 Key10419459
Report Number2183959-2020-03576
Device Sequence Number16879536
Product Code OTM
UDI-Device Identifier00878953005560
UDI-Public00878953005560
Combination Product (Y/N)N
Initial Reporter CountrySW
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) 08/18/2020
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 Expiration Date03/13/2020
Device Model Number720163-01
Device Catalogue Number720163-01
Device Lot Number0023895607
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/20/2020
Initial Report FDA Received Date08/18/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age71 YR
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