InjuryJCW
AMS 700 LGX MS PUMP
Received Jul 3, 2026 · Event occurred Jun 8, 2026
Report 2124215-2026-35830 · MDR key 25704827
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404253-12Catalog number
72404253-12
Lot number
1100525275
Product problems
- Fluid/Blood Leak
- Mechanical Problem
- Material Puncture/Hole
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100776454 MODEL/CATALOG DESCRIPTION: RESERVOIR UNIQUE IDENTIFIER (UDI) # (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. UPON INSPECTION, A HOLE IN THE TUBING GOING TO THE LEFT CYLINDER AND RELATED FLUID LOSS WERE IDENTIFIED. AS A RESULT, THE CYLINDER AND PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.