BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1057844 · Received June 6, 2008

    Report

    Report Number
    2182207-2008-03083
    Event Type
    Injury
    Date Received
    June 6, 2008
    Report Date
    May 9, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: CARRILLO-RUIZ JD, VELASCO F, JIMENEZ F, ET AL. BILATERAL ELECTRICAL STIMULATION OF PRELEMNISCAL RADIATIONS IN THE TREATMENT OF ADVANCED PARKINSON'S DISEASE. NEUROSURGERY 2008;62(2): 347-359. TREMOR AND RIGIDITY HAVE BEEN EFFICIENTLY CONTROLLED BY ELECTRICAL STIMULATION OF CONTRALATERAL PRELEMNISCAL RADIATION (RAPRL) IN PTS WITH UNILATERAL PARKINSON'S DISEASE. THE PRESENT STUDY DETERMINES THE EFFECT OF BILATERAL RAPRL ELECTRICAL STIMULATION IN A GROUP OF FIVE PTS WITH SEVERE BILATERAL TREMOR, RIGIDITY, AND BRADYKINESIA. EVALUATIONS WERE PERFORMED AT 3, 6, 9 AND 12 MOS POST-OPERATIVE, WITH 24 HR OFF MEDICATION-ON STIMULATION. REPORTABLE EVENT: PT 1 (CB) HAD AN INCREASE IN EMOTIONAL DEPRESSION SEVERITY THAT, ALTHOUGH ALREADY PRESENT IN THE PREOPERATIVE EVAL, REQUIRED ANTIDEPRESSIVE MEDICATION AFTER ES INITIATION. THE PT ALSO LOST 11 KG IN WEIGHT IN 6 MOS. ALTHOUGH THE PT BECAME ABLE TO WALK WITHOUT ASSISTANCE WITH EXCELLENT CONTROL OF TREMOR AND RIGIDITY, HIS EMOTIONAL CONDITION RENDERED HIS REHABILITATION DIFFICULT AND HE REMAINED DEPENDENT FOR DAILY LIVING ACTIVITIES. ASYMMETRICAL SETTING OF STIMULATION PARAMETERS BY DECREASING THE AMPLITUDE BY 1.0 V ON THE RIGHT AT MO 6 WAS ACCOMPANIED BY AN IMPROVEMENT IN THE PT'S EMOTIONAL CONDITION, ALTHOUGH HE CONTINUED TO REQUIRE ANTIDEPRESSANT MEDICATION. HE DID NOT REGAIN WEIGHT BUT STABILIZED IN THAT REGARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other NEURO STIMULATOR MODEL 7248 N=1| EXTENSION MODEL UNK N=2| PROGRAMMER MODEL UNK N=1| LEAD MODEL UNK N=1