BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1053618 · Received May 23, 2008

    Report

    Report Number
    2182207-2008-02764
    Event Type
    Injury
    Date Received
    May 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GRANZIERA C, POLLO C, RUSSMAN H, ET AL. SUB-ACUTE DELAYED FAILURE OF SUBTHALAMIC DBS IN PARKINSON'S DISEASE: THE ROLE OF MICRO-LESION EFFECT. PARKINSONISM RELAT DISORD 2008: 14(2):109-113. WE REVIEWED A COHORT OF 56 PD PATIENTS THAT UNDERWENT BILATERAL STEREOTACTIC STN IMPLANTATION AND WE STUDIED A SUBSET OF FIVE PATIENTS THAT, AFTER EARLY CLINICAL IMPROVEMENT, DEVELOPED A RAPIDLY PROGRESSIVE NEUROLOGICAL DETERIORATION UNRESPONSIVE TO DBS. PATIENTS PRESENTING DELAYED FAILURE (DF) DID NOT DIFFER FROM THE REST OF THE COHORT BY ANY OF THE PRE-OPERATIVE CHARACTERISTICS; THEREFORE, THE PRESENCE OF THIS MICRO-LESIONING EFFECT MIGHT BE CONSIDERED AS WARNING SIGN FOR PATIENTS THAT NEED A CAREFUL FOLLOW-UP. REPORTABLE EVENT: ALL COMPLAINED OF POSTURAL INSTABILITY LEADING TO FALLS IN FOUR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PROGRAMMER MODEL UNK N=1| LEAD MODEL 3389 N=1| IMPLANTABLE PULSE GENERATOR MODEL UNK N=1| EXTENSION MODEL UNK N=2