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

Model Number	72400165
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device: model number/catalog number 72400024, serial number (b)(4), batch/lot number 789116007, udi (b)(4), description balloon fgs 61-70 cm, expiration date 08/29/2017, manufacturer date 09/24/2012.
Event or Problem Description
It was reported that the patient had the artificial urinary sphincter cuff and balloon components removed due to unspecified reasons.The pump remained implanted.New artificial urinary sphincter cuff and balloon components were implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient had the artificial urinary sphincter cuff and balloon components removed due to unspecified reasons.The pump remained implanted.New artificial urinary sphincter cuff and balloon components were implanted.Further information was requested and not yet received.Should additional relevant details become available, 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.Updated to include device analysis.

• 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: 8413664
• Report Number: 2183959-2019-61497
• Device Sequence Number: 16590810
• Product Code: EZY
• UDI-Device Identifier: 00878953000763
• UDI-Public: 00878953000763
• 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: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/30/2015
• Device Model Number: 72400165
• Device Catalogue Number: 72400165
• Device Lot Number: 645554003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 05/04/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 05/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR