BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE EXTENSION

    MDR report key: 1053633 · Received May 23, 2008

    Report

    Report Number
    2182207-2008-02785
    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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: PENA E, PASTOR J, HERNANDO V, ET AL. SKIN EROSION OVER IMPLANTS IN DEEP BRAIN STIMULATION PTS. STEREOTACT FUNCT NEUROSURG 2008;86(2):120-126. WE ANALYZED FACTORS ASSOCIATED WITH SKIN EROSION IN 55 PTS TREATED WITH DEEP BRAIN STIMULATION (KINETRA OR SOLETRA) FOR PARKINSON'S (PD) OR OTHER DISEASES. NINE OF 55 PTS DEVELOPED EROSION, ALL OF WHOM WERE PD PTS WHO HAD BEEN FITTED WITH A KINETRA DEVICE. EROSION MAY BE DUE TO AN INCREASED PRESSURE OVER THE SKIN RESULTING FROM THE LARGER SIZE AND WEIGHT OF THE KINETRA DEVICE. REPORTABLE EVENT: A MALE PT WITH PARKINSON'S DISEASE WAS IMPLANTED WITH A KINETRA AND BILATERAL LEADS. AT 14 MONTHS POST, THE PT DEVELOPED EROSION IN THE SKIN ALONG THE EXTENSION CABLE TUNNEL PATHWAY IN THE SCALP BEFORE THE CONNECTION, ALONG WITH INFECTION. RECURRENCE OF EROSION DID OCCUR; THE ENTIRE STIMULATION SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE EXTENSION MHY MEDTRONIC NEUROMODULATION 7482 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R LEAD MODEL 3389 N=2| PROGRAMMER MODEL UNK N=1| EXTENSION MODEL 7482 N=1| NEURO STIMULATOR KINETRA MODEL 7428 N=1