AMS 700 CX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72018201. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100819268. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO ACHIEVE AN ERECTION AND EXPERIENCED PAIN. THE PATIENT WAS EVALUATED BY THE PHYSICIAN, WHO DETERMINED THAT THE DEVICE NEEDS TO BE REPLACED. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH IT WAS DETERMINED THAT THE PUMP REMAINED FLAT; AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.