AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) TUBING BECAME EXPOSED AT THE INFRAPUBIC INCISION SITE FOLLOWING THE ORIGINAL SURGERY. A FEW MONTHS LATER, THE PATIENT DEVELOPED SWELLING AND BACTERIAL INFECTION IN THE AREA OF THE EXPOSED TUBING. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A TACTRA AS A PLACEHOLDER. THE INCISION SITE WAS IRRIGATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404156, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1100593799, MODEL/CATALOG DESCRIPTION: RESERVOIR, 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 SYMPTOMS ARE KNOWN RISKS 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.