AMS 700 LGX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT ABLE TO INFLATE /PUMP. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A TACTRA DEVICE. UPON EXPLANT THE PHYSICIAN IDENTIFIED FLUID LEAKAGE BUT WAS UNABLE TO DETERMINE WHERE THE LEAK WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 0179071015 MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML UNIQUE IDENTIFIER (UDI) #: (B)(4).