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

Model Number UNK-P-AUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fever (1858)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.

Event Description

It was reported that the patient called with reports of experiencing continual fevers since the time of his artificial urinary sphincter (aus) implant on (b)(6) 2020.He states that initially his urologist had him on antibiotics and additionally he had an infected root canal that was addressed in (b)(6) 2020; however, he continues even now with daily fevers.The patient has contacted his physician who has assessed his system and feels that it is within normal limits as he has no other symptoms of infection (redness/swelling/drainage) and his aus is working normally for him.The patient wonders if his fevers are related to the antibiotic coating on the device.He is also consulting with an infectious disease doctor and he has an appointment with his urologist next week.Patient states he will patient liaison with an update.

• 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; minnentoka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 11446601
• MDR Text Key: 238678659
• Report Number: 2183959-2021-00841
• Device Sequence Number: 1
• Product Code: EZY
• Combination Product (y/n): Y
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-AUS
• Device Catalogue Number: UNK-P-AUS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR