AMS 700 LGX MS PUMP
Received Jul 21, 2026 · Event occurred Dec 1, 2025
Report 2124215-2026-39340 · MDR key 25896392
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404251Catalog number
72404251
Lot number
1100548790
Product problems
- Inflation Problem
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED FUNCTIONING AND EXHIBITED INFLATION ISSUE. THE REASON FOR THE DEVICE DEFICIENCY IS MOST LIKELY TO BE THE PUMP NOT WORKING, AS AN ULTRASOUND SHOWS THAT THERE WAS SUFFICIENT FLUID IN THE SYSTEM. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CYLINDERS AND PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100562397. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).