BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3884430 · Received June 19, 2014

    Report

    Report Number
    3007566237-2014-01723
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT HAD SWELLING APPARENTLY RELATED TO THE MORPHINE; THEY DECIDED TO REMOVE IT. DURING THE RINSE, THE PHYSICIAN NOTICED THAT THERE WAS BLOOD IN THE PUMP. AFTER THAT AND WHEN THE DEVICE WAS CLEAN, THE OLD MEDICATION WAS PLACED IN THE PUMP. SUBSEQUENTLY, THE SWELLING DISAPPEARED, BUT THE PATIENT HAD NO PAIN RELIEF. BECAUSE THE PATIENT HAD BLOOD IN THE PUMP AND THE PATIENT DID NOT HAVE RELIEF, THE PHYSICIAN ASSUMED THAT IT WAS DUE TO DEVICE MALFUNCTION AND DECIDED TO CHANGE IT. THE PUMP AND CONNECTOR WERE CHANGED. AT THE TIME OF THE REMOVAL THERE WAS BLOOD IN THE CONNECTOR. THE SAME MEDICATIONS WERE USED IN THE NEW PUMP. THE PATIENT HAD BEEN FOLLOWED CLOSELY AND REPORTED THAT THE PAIN WAS GETTING BETTER. THE SEVERITY OF THE EVENT WAS NOTED TO BE ¿MILD¿. THE OUTCOME OF THE EVENT WAS REPORTED AS ¿RECOVERED¿. THE PUMP WAS ALSO DELIVERING PRIALT, FENTANYL, CLONIDINE, AND BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361697 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention