BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1033613 · Received April 24, 2008

    Report

    Report Number
    2182207-2008-02173
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT TRIPPED OVER A CORD AND FELL DOWN TEN STEPS. AT THE BOTTOM OF THE STEPS, THE PT HIT THE AREA OF THE PUMP DIRECTLY ON THE CORNER OF A CHAIR. A LARGE HEMATOMA DEVELOPED WITH THE EPICENTER JUST BETWEEN THE CATHETER ACCESS PORT AND THE RIGHT EDGE OF THE PUMP. THE PUMP BEGAN ALARMING SHORTLY, THEREAFTER. THE PT WAS SEEN BY THE MANAGING HCP FIVE DAYS LATER, AND IT WAS FOUND THAT THE PUMP HAD STALLED ON THE DAY OF THE PT'S FALL. A TUBE SET ERROR MESSAGE WAS NOTED TWO DAYS LATER. THE PT REPORTED NAUSEA AND LIGHTHEADEDNESS. LATER THE PT ALSO REPORTED LACK OF EFFECT. A DYE STUDY WAS PERFORMED IN 2008 AND EVERYTHING APPEARED TO BE FINE, NO ROTOR STUDY WAS PERFORMED AT THAT TIME. THE NEXT DAY THE PT WAS SEEN, AND A ROTOR STUDY WAS PERFORMED WHICH REVEALED THAT THE ROTORS WERE NOT TURNING. IT WAS DETERMINED THAT RECOVERY WAS UNLIKELY. THE HCP AND PT DISCUSSED THE OPTIONS AND DECIDED TO TRY CONSERVATIVE TREATMENT, SO THE PT'S PUMP WAS PERMANENTLY STOPPED TO PREVENT ALARMS FROM BOTHERING THE PT, AND THE PT WAS STARTED ON ORAL MEDICATIONS. APPROX 20 DAYS AFTER THE FALL, IT WAS REPORTED THAT THE PT WAS NOT RECEIVING PAIN RELIEF FROM THE ORAL MEDICATIONS AND WANTED TO HAVE A NEW PUMP IMPLANTED. NO PT OUTCOME WAS REPORTED. THE PT'S PUMP CONTAINED MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention CATHETER MODEL 8709 LOT# N004905919 IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK