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

Model Number	72400164
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported that due to an prosthesis failure the patient had her artificial urinary sphincter (aus) removed and replaced.The aus was explanted and a new device consisting of a 4.0 cm cuff, pump and balloon were implanted.Should additional information be received a supplemental report will be submitted.
Event or Problem Description
It was reported that due to an prosthesis failure the patient had her artificial urinary sphincter (aus) removed and replaced.The aus was explanted and a new device consisting of a 4.0 cm cuff, pump and balloon were implanted.Should additional information be received a supplemental report will be submitted.
Additional Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegation was not confirmed via product analysis.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.Only the balloon was returned.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8524886
• Report Number: 2183959-2019-62351
• Device Sequence Number: 2689514
• Product Code: EZY
• UDI-Device Identifier: 00878953000756
• UDI-Public: 00878953000756
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/01/2021
• Device Model Number: 72400164
• Device Catalogue Number: 72400164
• Device Lot Number: 0128313011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention