BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1001547 · Received February 21, 2008

    Report

    Report Number
    2182207-2008-00812
    Event Type
    Injury
    Date Received
    February 21, 2008
    Report Date
    November 11, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ALTERMAN ET AL. "SIXTY HERTZ PALLIDAL DEEP BRAIN STIMULATION FOR PRIMARY TORSION DYSTONIA" 2007/69/7/681-8. THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF 60HZ DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) IN 15 CONSECUTIVE PTS WITH PRIMARY DYSTONIA. THE AUTHORS CONDUCTED A RETROSPECTIVE ANALYSIS OF CLINIC CHARTS RELATIVE TO 15 CONSECUTIVE PTS WITH MEDICALLY REFRACTORY PRIMARY DYSTONIA WHO UNDERWENT STEREOTACTIC IMPLANTATION OF DBS LEADS WITHIN THE GPI. THEY FOUND THAT ALL PTS TOLERATED DBS TREATMENT WELL AND CONCLUDED THAT STIMULATION OF THE GPI AT 60 HZ IS SAFE AND EFFECTIVE FOR TREATING MEDICALLY REFRACTORY PRIMARY DYSTONIA. AFTER IMPLANTATION OF THE DBS STIMULATOR, SURGICAL COMPLICATIONS WERE RESTRICTED TO TWO HARDWARE-RELATED WOUND INFECTION. BOTH DEVICES (INS MODEL 7426 N=2) WERE REMOVED AND NEW DEVICES IMPLANTED FOLLOWING AN APPROPRIATE COURSE OF IV ANTIBIOTICS. THERE WERE NO SERIOUS ADVERSE EVENTS RELATED TO THE INFECTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R LEAD EXTENSION MODEL 7482 (N=1)| FOR EACH PATIENT LEAD MODEL 3387 (N=1)