AMS 700? CX TENACIO? PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1100702113, MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML, UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT THE DEVICE NEVER REALLY WORKED PROPERLY. THE PATIENT FEELS LIKE THERE IS NO FLUID MOVING THROUGH THE SYSTEM AND IT BARELY INFLATES. FOUR-WEEK POST OPERATION, THE PHYSICIAN GIVES THE OK TO THE PATIENT TO USE THE DEVICE AND CYCLE IT; HOWEVER, THE PATIENT WAS IN PAIN AND WAS STILL QUITE BRUISED TO ATTEMPT TO CYCLE AT THAT TIME. THE PATIENT HAD AN APPOINTMENT WITH A DIFFERENT PHYSICIAN; HOWEVER, WAS NOT HELPFUL. THE DEVICE WAS FOUND TO BE PART OF THE TENACIO RECALL. NO ADDITIONAL INFORMATION WAS PROVIDED.