AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE PRESENTED TO THEIR IMPLANTING PHYSICIAN AS THEY WERE UNABLE TO INFLATE THEIR IPP DEVICE. THE PATIENT REPORTED THAT INITIALLY THE PUMP FELT VERY HARD. THE PHYSICIAN PERFORMED A PHYSICAL EXAMINATION AND WAS UNABLE TO INFLATE THE IPP DEVICE WHEN PRESSING THE PUMP. ULTRASOUND STUDIES WERE PERFORMED AND CONFIRMED THAT THE RESERVOIR WAS INTACT AND CONTAINED FLUID INSIDE. THE PHYSICIAN BELIEVED THAT THE MOST LIKELY/SUSPECTED CAUSE WAS THE PUMP COMPONENT. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720182-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: UNKNOWN. MODEL/CATALOG DESCRIPTION: RESERVOIR, FLAT, 100 ML. UNIQUE IDENTIFIER (UDI) #: UNKNOWN. AT THIS TIME, THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED THE FINAL REPORT WILL BE SUBMITTED.