AMS 700 LGX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1100726327, MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML, UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) HAD PEYRONIES DISEASE AND THAT THE DEVICE WAS UNDERSIZED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP WITH AN APPROPRIATELY SIZED CYLINDER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.