AMS 700? CX TENACIO? PUMP

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(S) 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. MODEL NUMBER/CATALOG NUMBER: 720185-01, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1100812145, 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 PAIN. THE PHYSICIAN STATED THAT THE PREVIOUS IMPLANT WAS OVERSIZED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH APPROPRIATE SIZE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.