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

Model Number	72400025
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 event date: estimated.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent incontinence.It was also noted that his urine stream had decreased to a dribble.He noted that his device had recently stopped working.The pump feels extremely hard and will not depress.The patient presented at his clinic and was directed to go to the emergency room (er) as he could not be seen in clinic for a month.The patient services consultant discussed potential device deactivation and also referred him to the er due to possible urinary retention.No additional patient complication were reported.
Additional Manufacturer Narrative
B3 event date: estimated.Correction to block d4.Block d6a.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced recurrent incontinence.It was also noted that his urine stream had decreased to a dribble.He noted that his device had recently stopped working.The pump feels extremely hard and will not depress.The patient presented at his clinic and was directed to go to the emergency room (er) as he could not be seen in clinic for a month.The patient services consultant discussed potential device deactivation and also referred him to the er due to possible urinary retention.No additional patient complication were reported.

• 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: 19555658
• Report Number: 2124215-2024-36491
• Device Sequence Number: 6716500
• Product Code: EZY
• UDI-Device Identifier: 00878953000633
• UDI-Public: 00878953000633
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 02/04/2024
• Device Model Number: 72400025
• Device Catalogue Number: 72400025
• Device Lot Number: 1000226549
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/14/2024
• Date Device Manufactured: 02/05/2019
• 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: CUFF 720157-01/1000174321; PUMP 72404127/1000212910
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male