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

Model Number	72400023
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported that due to an unspecified reason the patient had his artificial urinary sphincter (aus) 61-70 cm pressure regulating balloon (prb) removed and replaced with a 71-80 cm prb.It was further reported that the patient was experiencing "spontaneous leakage" and the physician wanted to increase the balloon pressure from 61-70 cm to 71-80 cm balloon.It was noted that the approach for this surgery was in the abdominal area where the old balloon was located and the new balloon was connected with pump and cuff at the same location.There was no handing of the old cuff and pump.The onset of the patient symptoms was two months previous to this surgery.The patient was stable after this surgery and the system will be activated a week after this surgery.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9629003
• Report Number: 2183959-2020-00236
• Device Sequence Number: 14174036
• Product Code: EZY
• UDI-Device Identifier: 00878953000619
• UDI-Public: 00878953000619
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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: 06/30/2021
• Device Model Number: 72400023
• Device Catalogue Number: 72400023
• Device Lot Number: 0143070015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR