BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 10355061 · Received August 3, 2020

    Report

    Report Number
    3004209178-2020-13265
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    July 23, 2020
    Report Date
    August 3, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630512
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING HEPARIN SALINE (1250 UNITS/ML AT 1248.8 UNITS/DAY) VIA AN IMPLANTED PUMP. THE PATIENT¿S MEDICAL HISTORY WAS NOTED TO BE STAGE FOUR LIVER CANCER WITH TREATMENT VIA HEPATIC ARTERIAL INFUSION USING THE PUMP AND PUMP CONNECTOR ATTACHED TO A CATHETER MADE BY ANOTHER MANUFACTURER. ON (B)(6) 2020 IT WAS REPORTED THAT THE PATIENT DEVELOPED A LOCAL INFECTION AT THE PUMP POCKET LOCATION ONE MONTH AFTER IMPLANT. NO DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED. THE SURGEONS DECIDED THAT THE BEST SOLUTION TO THE INFECTION AT THE PUMP POCKET WAS TO EXPLANT THE PUMP AND IMPLANT A NEW PUMP IN A DIFFERENT LOCATION IN THE PATIENT¿S ABDOMEN. ON (B)(6) 2020 THE PUMP AND SUTURELESS CONNECTOR WERE REMOVED AND A NEW PUMP AND CONNECTOR WERE IMPLANTED AT A DIFFERENT LOCATION IN THE PATIENT¿S ABDOMEN TO ALLOW THE INFECTION AT THE PREVIOUS IMPLANT SITE TO HEAL AND NOT SPREAD AND TO RESUME HAI (HEPATIC ARTERIAL INFUSION) CANCER THERAPY. IT WAS NOTED THAT THE PUMP AND CONNECTOR WERE ATTACHED TO A CATHETER MADE BY ANOTHER MANUFACTURER. THE ISSUE WAS NOTED TO BE RESOLVED AND IT WAS INDICATED THAT THE HCP HAD NO FURTHER INFORMATION TO PROVIDE REGARDING THE EVENT. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE ¿ NO INJURY¿. THE FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE NOTED TO BE THAT THE PATIENT¿S PUMP WAS IMPLANTED TO TREAT STAGE FOUR LIVER CANCER VIA HEPATIC ARTERIAL INFUSION AND THE PATIENT WAS IMMUNOCOMPROMISED AND MORE SUSCEPTIBLE TO INFECTIONS AS A RESULT OF THE CANCER BEING TREATED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820538 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169630512

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention