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

Model Number	72400165
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4) and for balloon is (b)(4).
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was no longer functioning as intended and was confirmed by the physician to not be working properly.The patient has undergone enterocystoplasty for the small capacity and pain of the bladder.The aus was explanted and replaced with robotic-assisted laparoscopic surgery.There were no additional patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4) and for balloon is (b)(4).
Event or Problem Description
It was reported that this artificial urinary sphincter (aus) was no longer functioning as intended and was confirmed by the physician to not be working properly.The patient has undergone enterocystoplasty for the small capacity and pain of the bladder.The aus was explanted and replaced with robotic-assisted laparoscopic surgery.There were no additional patient complications reported.

• Brand Name: AMS 800 ARTIFICIAL URINARY SPHINCTER
• 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: 22150435
• Report Number: 2124215-2025-36822
• Device Sequence Number: 18259850
• Product Code: EZY
• UDI-Device Identifier: 00878953000763
• UDI-Public: (01)00878953000763(17)171029(10)798260004
• 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: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: 10/29/2017
• Device Model Number: 72400165
• Device Catalogue Number: 72400165
• Device Lot Number: 798260004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 10/22/2012
• 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: UPN:72400024 LOT:812585014 BALLOON.; UPN:72400024 LOT:812585014 BALLOON.; UPN:72400098 LOT:816485009 PUMP.; UPN:72400098 LOT:816485009 PUMP.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female