AMS 800 Urinary Control System
Received Jul 29, 2026 · Event occurred Nov 26, 2025
Report 2124215-2026-40563 · MDR key 50069135
Device
Generic name
Device Incontinence Mechanical/hydraulic
Manufacturer
Boston Scientific CorporationModel number
UNK-P-AUSCatalog number
UNK-P-AUS
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Muscle Weakness/Atrophy
- Urinary Incontinence
Narrative
Description of Event or Problem
It was reported that a patient implanted with an Artificial Urinary Sphincter (AUS) experienced recurrent urinary incontinence. A surgical procedure was performed, during which tissue atrophy was identified. No device related issues were noted. To address the condition, a new cuff, pump, and pressure regulating balloon (PRB) were implanted. No additional patient complications were reported.
Additional Manufacturer Narrative
Detailed product information was not provided to BSC. We completed a good faith effort to obtain the information. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other product specific information. If additional details become available, a supplemental report will be submitted.