MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number UNK-P-SLING-MENS ADVANCE XP

Device Problem Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

It was reported by the patient that his unspecified sling device has "failed." the sling was implanted approximately seven weeks earlier.Now the patient states his incontinence is worse than before he had the sling device implanted.He is wanting to talk to someone about having the artificial urinary sphincter (aus) device implanted.Additional information received states the "dr has been in contact with this patient.He is (b)(6) years old and he and his family were told at the time of surgery that his changes of being dry were very slim but patient insisted on proceeding with a sing vs a sphincter.His sling was an advance xp.".

• 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 Key: 9498085
• MDR Text Key: 176974676
• Report Number: 2183959-2019-68269
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-SLING-MENS ADVANCE XP
• Device Catalogue Number: UNK-P-SLING-MENS ADVANCE XP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR