AMS 700 LGX MS PUMP
Received Jul 13, 2026 · Event occurred Jun 17, 2026
Report 2124215-2026-37525 · MDR key 25806678
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404252Catalog number
72404252
Lot number
0169028005
Product problems
- Fluid/Blood Leak
- Inflation Problem
- Air/Gas in Device
Patient
73 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. DURING A SURGICAL PROCEDURE, FLUID LOSS WAS OBSERVED, AS THE RESERVOIR WAS FOUND TO BE EMPTY; HOWEVER, THE SOURCE OF THE FLUID LOSS WAS NOT IDENTIFIED. ADDITIONALLY, AIR WAS DETECTED IN THE PUMP. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404156. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0156775001. MODEL/CATALOG DESCRIPTION: RESERVOIR 100 ML PC/IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4).