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

Model Number	720133-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Urinary Retention (2119); Urinary Incontinence (4572)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with continued incontinence after the implant of the device.The physician performed testing and determined the device was working normally.The patient states that the device is no longer working and they would like another physician to evaluate the device.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) presented with urinary retention in the postoperative period and then total urinary incontinence after.The physician performed testing and determined the device was working normally.The patient was evaluated by another physician and the physician determined the aus would need to be replaced.There has been no surgical intervention and no additional patient complications reported.
Additional Manufacturer Narrative
Updated b5 describe event or problem and h6 patient codes.

• 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: 20096215
• Report Number: 2124215-2024-54046
• Device Sequence Number: 8475277
• Product Code: EZY
• UDI-Device Identifier: 00878953005461
• UDI-Public: 00878953005461
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/23/2024

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 Expiration Date: 10/25/2024
• Device Model Number: 720133-01
• Device Catalogue Number: 720133-01
• Device Lot Number: 1100206930
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/23/2024
• Date Device Manufactured: 10/26/2022
• 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: 72400024 LOT#: 1100322399; BALLOON: UPN: 72400024 LOT#: 1100322399; PUMP: UPN: 72400098 LOT#: 1100360478; PUMP: UPN: 72400098 LOT#: 1100360478
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male