AMS 700 LGX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100357271. 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) WOULD NOT INFLATE AND THE PUMP WOULD STAY FLAT. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN IDENTIFIED A HOLE IN THE RESERVOIR TUBING AND FLUID LEAKAGE. THE NEW DEVICE WAS TESTED AND WAS FULLY FUNCTIONAL. THE PATIENT FULLY RECOVERED, AND THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED.