MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 Artificial Urinary Sphincter; Device Incontinence Mechanical/Hydraulic

Model Number	72400160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent urinary incontinence.The patient had a previously implanted double cuff aus consisting of a 4.0 cm cuff and a 4.5 cm cuff.A surgical procedure was performed during which the cuffs, balloon, and control pump were explanted.The aus system was replaced with a 4.0 cm cuff, a 61-70 balloon, and a new control pump.No additional patient complications were reported.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent urinary incontinence.The patient had a previously implanted double cuff aus consisting of a 4.0 cm cuff and a 4.5 cm cuff.A surgical procedure was performed during which the cuffs, balloon, and control pump were explanted.The aus system was replaced with a 4.0 cm cuff, a 61-70 balloon, and a new control pump.No additional patient complications were reported.
Additional Manufacturer Narrative
This report is being submitted to correct the date of event field (b3) in section b, adverse event/product problem.Concomitant products implanted: model number/catalog number: 72400161 serial number: n/a batch/lot number: 356386006 model/catalog description: belt cuff fgs 4.5 cm unique identifier (udi) #:(b)(4).Model number/catalog number: 72400024 serial number: n/a batch/lot number: 361693009 model/catalog description: balloon fgs 61-70 cm unique identifier (udi) #:(b)(4).Model number/catalog number: 72400098 serial number: n/a batch/lot number: 363316016 model/catalog description: control pump fgs unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
Concomitant products implanted: model number/catalog number: 72400161 serial number: n/a batch/lot number: 356386006 model/catalog description: belt cuff fgs 4.5 cm unique identifier (udi) #: ((b)(4).

• 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: 50568998
• Report Number: 2124215-2026-46809
• Device Sequence Number: 16073066
• Product Code: EZY
• UDI-Device Identifier: 00878953000718
• UDI-Public: (01)00878953000718(17)071205(10)360927007
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 12/05/2007
• Device Model Number: 72400160
• Device Catalogue Number: 72400160
• Device Lot Number: 360927007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 10/02/2026
• 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: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male