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

Model Number	72404138
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Incontinence (1928); Tissue Damage (2104)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product component: model number/catalog number 72400024 and 72404127, serial number: null and null, batch/lot number 882198014 and 895209012, model/catalog description balloon fgs 61-70cm and control pump fgs iz.
Event or Problem Description
It was reported that patient experienced recurring incontinence due to atrophy with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon were explanted and a new 7.5cm aus cuff, pump and balloon were implanted.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8166947
• Report Number: 2183959-2018-61708
• Device Sequence Number: 13943410
• Product Code: EZY
• UDI-Device Identifier: 00878953003160
• UDI-Public: 00878953003160
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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: 08/06/2015
• Device Model Number: 72404138
• Device Catalogue Number: 72404138
• Device Lot Number: 893664016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/14/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention