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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 12/16/2020
Event Type  Injury  
Event Description
It was reported that the patient had an advance xp implanted in 2020.The sling did not improve his incontinence.A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted.The patient was in recovery following the surgery.
 
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Brand Name
AMS ADVANCE XP SLING SYSTEM
Type of Device
MESH 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 Key11142657
MDR Text Key226003979
Report Number2183959-2020-06323
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/08/2021
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? 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
Initial Date Manufacturer Received 12/16/2020
Initial Date FDA Received01/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
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