MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 Artificial Urinary Sphincter; Device incontinence mechanical/hydraulic

Model Number	72404127
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Migration is acknowledged within the instructions for use (ifu) and is not related to off-label use or failure to follow instructions.
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) presented with a control pump that was inaccessible in the scrotum.A revision surgery was performed, during which the physician confirmed that the control pump had migrated from its intended implant location on the right side of the anterior scrotum to the right far dependent scrotum underneath the testicle, rendering it inaccessible to the patient.The control pump was explanted and replaced.There were no patient complications.
Event or Problem Description
It was reported that a patient with an artificial urinary sphincter (aus) presented with a control pump that was inaccessible in the scrotum.A revision surgery was performed, during which the physician confirmed that the control pump had migrated from its intended implant location on the right side of the anterior scrotum to the right far dependent scrotum underneath the testicle, rendering it inaccessible to the patient.The control pump was explanted and replaced.There were no patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Migration is acknowledged within the instructions for use (ifu) and is not related to off label use or failure to follow instructions.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event of migration was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of adverse event related to procedure was assigned to this investigation.There are procedural-related factors that may have contributed to the observed issue.According to timeline regarding implantation of device, this event is most likely related to post-operative adverse events referenced within instructions for use and hazard analysis documentation.

• 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 ; +1(508)652-1217
• MDR Report Key: 25820982
• Report Number: 2124215-2026-37878
• Device Sequence Number: 10411896
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• UDI-Public: (01)00878953003078(17)280122(10)1100880896
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/11/2026

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 Model Number: 72404127
• Device Catalogue Number: 72404127
• Device Lot Number: 1100880896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 01/22/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male