InjuryJCW
AMS 700 CX MS PUMP
Received Jul 20, 2026 · Event occurred Jun 24, 2026
Report 2124215-2026-38951 · MDR key 25883636
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404233-12Catalog number
72404233-12
Lot number
1100277792
Product problems
- Fluid/Blood Leak
- Mechanical Problem
- Material Puncture/Hole
Patient
53 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT WOULD NOT CYCLE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN IDENTIFIED A HOLE AT THE CONNECTION OF THE EXIT TUBING AND THE CYLINDER, RESULTING IN A FLUID LEAK. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.