AMS 700 LGX? TENACIO? PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100589277. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #:(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT FOLLOWING INITIAL ACTIVATION OF THIS INFLATABLE PENILE PROSTHESIS (IPP); THE DEVICE EXHIBITED SPONTANEOUS DEFLATION DURING INTERCOURSE. THE PATIENT CONSULTED THEIR PHYSICIAN AND WAS GUIDED TO WAIT FOR AN ADDITIONAL PERIOD BEFORE ATTEMPTING USE OF THE DEVICE. APPROXIMATELY 3-4 MONTHS AFTER IMPLANT, THE PATIENT WAS GIVEN CLEARANCE TO USE THE DEVICE ONCE MORE AND THE PATIENT EXPERIENCED SPONTANEOUS DEFLATION AGAIN. A SURGICAL PROCEDURE WAS THEN PERFORMED DURING WHICH THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.