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

Model Number	72400023
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter experienced recurrent incontinence approximately one and a half years post-implant.It was confirmed that the balloon was damaged.No new device will be implanted due to the patient condition of dementia.No further patient complications were reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter experienced recurrent incontinence approximately one and a half years post-implant.It was confirmed that the balloon was damaged.No new device will be implanted due to the patient's condition of dementia.No further patient complications were reported.
Additional Manufacturer Narrative
Correction to block b3 and d6a.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19483404
• Report Number: 2124215-2024-33280
• Device Sequence Number: 8139374
• Product Code: EZY
• UDI-Device Identifier: 00878953000619
• UDI-Public: 00878953000619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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 Model Number: 72400023
• Device Catalogue Number: 72400023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown