MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number UNK-P-AUS

Device Problem Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 02/06/2020

Event Type  malfunction  

Event Description

It was reported that following an artificial urinary sphincter implant in (b)(6) 2018, the patient stated the medication he has been on were drying him out so bad that he was back to using two depends at a time.The patient indicated he could not live like this anymore and was thinking about going back to see the physician.The physician indicated to the patient that he was not the best surgical candidate because of all his comorbidities.The patient indicated he had seen seven different urologists.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Type of Device: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• 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: 9772557
• MDR Text Key: 183156324
• Report Number: 2183959-2020-00971
• Device Sequence Number: 1
• Product Code: EZY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/29/2020

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-AUS
• Device Catalogue Number: UNK-P-AUS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/29/2020
• 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