AMS 700 LGX? TENACIO? PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100749499. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISCOMFORT. THE DEVICE WAS NOTED TO BE IMPROPERLY POSITIONED AND OVERSIZED. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED WITH A SMALLER SIZE, WHILE THE RESERVOIR WAS RETAINED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.