AMS 700 LGX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. A COMPUTED TOMOGRAPHY (CT) SCAN INDICATED THAT THE RESERVOIR CONTAINED NO FLUID. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH A TEAR IN THE LEFT CYLINDER WAS IDENTIFIED. THE RESERVOIR WAS ALLOWED TO DRAIN AND WAS RETAINED, AND A NEW RESERVOIR WAS IMPLANTED. THE RECONNECT WAS ALSO REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 0178837016 MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML UNIQUE IDENTIFIER (UDI) #: (B)(4).