AMS 700 LGX MS PUMP
Received Jun 17, 2026 · Event occurred Jun 4, 2026
Report 2124215-2026-32333 · MDR key 25535461
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404251Catalog number
72404251
Lot number
1000337800
Product problems
- Fluid/Blood Leak
- Mechanical Problem
- Material Puncture/Hole
Patient
72 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404155. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000451610. MODEL/CATALOG DESCRIPTION: RESERVOIR 65 ML PC/IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN IDENTIFIED A TEAR IN ONE OF THE CYLINDERS AND LOSS OF FLUID AS THERE WAS NO FLUID IN THE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.