AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN. THE PUMP WAS NOTED TO BE FIXED WITHIN THE SCROTUM, AND THE PHYSICIAN EXPRESSED CONCERN FOR POSSIBLE INFECTION; HOWEVER, NO SIGNS OF INFECTION WERE IDENTIFIED. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOM IS A KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100851926. MODEL/CATALOG DESCRIPTION: RESERVOIR. UNIQUE IDENTIFIER (UDI) # (B)(4).