AMS 700 LGX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED LOWER ABDOMINAL PAIN. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE RESERVOIR WAS FOUND TO HAVE HERNIATED OUT OF THE SPACE OF RETZIUS. THE RESERVOIR WAS REPLACED WITH A NEW CONCEAL RESERVOIR, WHILE THE CYLINDERS AND PUMP WERE INSPECTED AND FOUND TO BE INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100827671. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).