BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1904478 · Received November 14, 2010

    Report

    Report Number
    1904478
    Event Type
    Malfunction
    Date Received
    November 14, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 12, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A LONG HISTORY OF PARKINSON'S DISEASE REPORTS THAT HE HAS HAD WORSENING TREMORS ON THE LEFT SIDE OF HIS BODY FOR THE PAST 2 MONTHS. HE INITIALLY HAD A PALLIDOTOMY ON THE LEFT AT AN OUTSIDE FACILITY, FOLLOWED BY A DEEP BRAIN STIMULATOR (DBS) PLACEMENT UNILATERALLY (ON THE RIGHT), AT ANOTHER OUTSIDE FACILITY, WITH MOST RECENT IPG REPLACEMENT ~3 YEARS AGO. HE IS CONCERNED THAT OVER THE LAST SEVERAL MONTHS HIS STATE HAS WORSENED, THAT HE HAS HAD WORSENING WEAKNESS, AS WELL AS TREMORS ON HIS LEFT SIDE. THE PATIENT WAS SEEN AT YET ANOTHER FACILITY SEVERAL DAYS AGO, AND WAS ADMITTED ON RECENTLY WITH WORSENING WEAKNESS AND TREMULOUSNESS. THERE WAS THOUGHT THAT PERHAPS HIS DEEP BRAIN STIMULATOR WAS DYSFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR