BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1272793 · Received December 22, 2008

    Report

    Report Number
    2182207-2008-08506
    Event Type
    Injury
    Date Received
    December 22, 2008
    Report Date
    December 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P860009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ELLIS TM, FOOTE KD, FERNANDEZ HH, ET AL. REOPERATION FOR SUBOPTIMAL OUTCOMES AFTER DEEP BRAIN STIMULATION SURGERY. NEUROSURGERY. 2008;63(4):754-761. TO EXAMINE A CASE SERIES OF REOPERATIONS FOR DEEP BRAIN STIMULATION (DBS) LEADS IN WHICH CLINICAL SCENARIOS REVEALED SUBOPTIMAL OUTCOME OF PREVIOUS OPERATION. SUBOPTIMALLY PLACED DBS LEADS ARE ONE POTENTIAL REASON FOR UNSATISFACTORY RESULTS AFTER SURGERY FOR PARKINSON'S DISEASE (PD), ESSENTIAL TREMOR (ET), OR DYSTONIA. DEVICE MFR OF THE DBS PRODS WAS NOT IDENTIFIED. REPORTABLE EVENT: CASES OF LEAD REPLACEMENT DUE TO PREVIOUS SUBOPTIMAL CLINICAL BENEFIT WERE INCLUDED IN THE STUDY. A TOTAL PTS WITH 25 LEADS WITH SUBOPTIMAL OUTCOMES WERE STUDIED, OUT FO A TOTAL OF 456 LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization PROGRAMMER: MODEL UNK| LEAD: MODEL UNK| EXTENSON: MODEL UNK