AMS 700 LGX MS PUMP

Additional Manufacturer Narrative

B3: DATE IS UNKNOWN, SO ESTIMATED DATE WAS ENTERED. MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 182468012. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED INFLATING. UPON A CLINIC VISIT WITH THEIR PHYSICIAN, THE PHYSICIAN HAD A COMPUTED TOMOGRAPHY (CT) SCAN DONE WHICH CONFIRMED THE RESERVOIR DID NOT HAVE ANY FLUID. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE EXPLANT THE PHYSICIAN SUSPECTED THERE WAS A LEAK FROM THE TUBING THAT CONNECTED ONE OF THE CYLINDERS TO THE PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.