AMS 700 LGX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404161. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100324104. MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC. UNIQUE IDENTIFIER (UDI) #: (B)(4). 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 SYMPTOMS OF INFECTION AND PERFORATION ARE KNOWN RISKS 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 A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN INFLAMMATORY REACTION AND THE CYLINDER EXTRUDED THROUGH THE URETHRA. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE CYLINDERS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.