AMS 700? CX TENACIO? PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404156, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1100531001, MODEL/CATALOG DESCRIPTION: RESERVOIR 100 ML PC/IZ, UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED. THEREFORE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY AND EXHIBITED INFLATION ISSUES. A SURGICAL INTERVENTION WAS SUBSEQUENTLY PERFORMED, DURING WHICH IT WAS NOTED THAT, DURING THE INITIAL IMPLANTATION, THE RIGHT CYLINDER APPEARED TO HAVE BEEN IMPROPERLY POSITIONED. ADDITIONALLY, THE PUMP WAS FOUND TO BE POSITIONED HIGH WITHIN THE SCROTUM. THE IPP WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.