AMS 700? CX TENACIO? Pump

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404156 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100743450 MODEL/CATALOG DESCRIPTION: RESERVOIR 100 ML PC/IZ UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY INFLATING THE DEVICE AND STATED THAT EXCESSIVE AND FORCEFUL PUMPING WAS REQUIRED, WHICH WAS CHALLENGING DUE TO HIS HYDROCELE. THE DEVICE NEVER REALLY INFLATED PROPERLY. TROUBLESHOOTING WAS PERFORMED, INCLUDING SEVERAL APPOINTMENTS AND TRAINING SESSIONS; HOWEVER, IT WAS UNSUCCESSFUL IN RESOLVING THE ISSUE. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.