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

Model Number	72404144
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant date, lot number, manufacture date and expiration date were unable to be obtained though good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to have an artificial urinary sphincter (aus) cuff explanted and a new smaller aus cuff implanted due to recurring incontinence.The physician believed that a smaller cuff size would resolve the issue.No patient complications were reported.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14502217
• Report Number: 2124215-2022-18276
• Device Sequence Number: 5658393
• Product Code: EZY
• UDI-Device Identifier: 00878953003191
• UDI-Public: 00878953003191
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: 08/18/2022
• Device Model Number: 72404144
• Device Catalogue Number: 72404144
• Device Lot Number: 1000446589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON UPN: 72400025 LOT#: 1000513363; PUMP UPN: 72404127 LOT#: 1000521420
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male