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

Model Number UNK-P-SLING-MENS_ADVANCE

Device Problems Mechanical Problem (1384); Defective Device (2588)

Patient Problem Incontinence (1928)

Event Date 01/01/2020

Event Type  malfunction  

Event Description

It was reported that patient states he had prostate cancer and had it removed, in (b)(6) 2019.He was having leaking problems due to his prostatectomy.In (b)(6) 2020, patient had an advance male sling system implanted.Patient is experiencing urinary incontinence at night about 2 or 3 times a week.Doctor gave patient a months supply of myrbetriq.It seemed to work, but apparently has worn off.Patient is disappointed that sling did not work and does not want an artificial urinary sphincter (aus).He states nothing seems to work for him, no matter what it is.Patient liaison spoke with patient regarding his sling device.Patient liaison states that a physician assessment is needed to understand the patient leakage.Patient will consult with a friend to see what his suggestions are for a device that does not work.

• Brand Name: AMS ADVANCE SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 10036931
• MDR Text Key: 191119670
• Report Number: 2183959-2020-02220
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053371
• 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: 05/07/2020

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
• Device Catalogue Number: UNK-P-SLING-MENS_ADVANCE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/07/2020
• 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