BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2093636 · Received May 12, 2011

    Report

    Report Number
    9614453-2011-03480
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED WITH 2 LEADS IN THE STN IN EARLY (B)(6). ON (B)(6) 2011, TWO IMPLANTABLE NEUROSTIMULATORS (INS) WERE IMPLANTED. THE INITIAL ACTIVATION AND FIRST PROGRAMMING OF THE 2 INS OCCURRED ON (B)(6) 2011, WITHOUT ANY PROBLEMS. THE NEXT DAY, THE NEUROLOGIST PERFORMED A PROGRAMMING SESSION TO CHECK AND ADAPT THE PARAMETERS IF NEEDED. HE STARTED WITH THE RIGHT INS (CORRESPONDING TO THE RIGHT STN) AND IT WORKED PROPERLY. THEN HE TRIED TO INTERROGATE THE LEFT INS (CORRESPONDING TO LEFT STN). HE DID NOT SUCCEED THE FIRST TWO TIMES DUE TO BANDAGES. BUT DURING THE 3RD ATTEMPT OF INS INTERROGATION, THE PT EXPERIENCED A VERY SEVERE AND INTENSE PAINFUL DYSTONIA EPISODE, MAINLY LOCATED IN THE RIGHT ARM/SHOULDER (CONTROLATERAL SIDE TO IMPLANTED INS), FOR ABOUT 15-20 SECONDS. AFTER THIS EPISODE, THEY WERE ABLE TO INTERROGATE THE INS, WHICH WAS DE-PROGRAMMED BACK TO DEFAULT (MFG) SETTINGS. IT WAS NOTED THAT THE BANDAGES HAD NOT BEEN CHANGED AT THE TIME THE INCIDENT OCCURRED, AND THEY WERE QUITE WET. THEY WERE ABLE TO REPROGRAM THE IPG NORMALLY AND THE PT GOT A GOOD CLINICAL EFFECT FROM HIS STIMULATION, RULING OUR LEAD MIGRATION. REVIEW OF THE INTERROGATION FROM THE DAY OF THE EVENT NOTED NO ABNORMALITIES. FOLLOWING THE EPISODE, THE PT CONTINUED TO EXPERIENCE SHOULDER PAIN. IT WAS FOUND THAT THE PT'S SHOULDER WAS BROKEN AS A RESULT OF THE DYSTONIC EPISODE. THE PT UNDERWENT SURGERY TO FIX THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC EUROPE SARL 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention