AMS 700 LGX MS PUMP
Received Jun 25, 2026 · Event occurred Jan 1, 2020
Report 2124215-2026-34023 · MDR key 25630689
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404253Catalog number
72404253
Lot number
643091003
Product problems
- Fluid/Blood Leak
- Mechanical Problem
Patient
82 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404156. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 639266001. MODEL/CATALOG DESCRIPTION: RESERVOIR 100 ML PC/IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4). B3: DATE IS UNKNOWN, SO ESTIMATED DATE WAS ENTERED.
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING AS IT WOULD NOT ACTUATE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN IDENTIFIED FLUID LEAKAGE BUT NOT HOLE WAS APPARENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.