AMS 700 CX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100824541. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED GLANS NECROSIS, WHICH BEGAN SHORTLY AFTER THE IMPLANT WAS PLACED. THE GLANS WAS NOTED TO BE TURNING BLACK, LEADING TO THE IDENTIFICATION OF NECROSIS, WHICH WAS DIAGNOSED VIA VISUAL EXAMINATION. THE PATIENT WAS CONSIDERED PREDISPOSED TO THIS CONDITION DUE TO COMPROMISED BLOOD FLOW. NO DEVICE ISSUES WERE REPORTED. A SURGICAL PROCEDURE WAS PERFORMED TO EXPLANT THE IPP. NO NEW IPP WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.