AMS 700 LGX? TENACIO? PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404155. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100740514. MODEL/CATALOG DESCRIPTION: RESERVOIR 65 ML PC/IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOM AND THE MIGRATION ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, THE CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED CYLINDER MIGRATION. DURING A SUBSEQUENT SURGICAL PROCEDURE, BILATERAL CYLINDER PERFORATIONS WERE IDENTIFIED, INVOLVING THE PROXIMAL CORPORA ON THE RIGHT SIDE AND THE MEDIAL CORPORA ON THE LEFT SIDE. TO ADDRESS THESE FINDINGS, THE MEDIAL LEFT PERFORATION WAS SURGICALLY CLOSED, AND NEW CORPORAL PATHWAYS WERE CREATED THROUGH DILATION USING A PENOSCROTAL APPROACH. THE EXISTING IPP DEVICE WAS COMPLETELY REMOVED. A NEW IPP SYSTEM WAS SUCCESSFULLY IMPLANTED WITHOUT COMPLICATIONS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.