BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINAL CORD STIMULATION DEVICES

    MDR report key: 921658 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03040
    Event Type
    Other
    Date Received
    September 21, 2007
    Report Date
    June 11, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: DELYE, H. ET AL. "THALAMIC STIMULATION AS A TREATMENT FOR PRIMARY ERYTHROMEALGIA: TECHNICAL CASE REPORT." NEUROSURGERY 2005; 57: ONS-404. THE JOURNAL ARTICLE DISCUSSED THE USE OF BILATERAL THALAMIC STIMULATION ON A MALE PT FOR ERYTHROMEALGIA FOR 3 YEARS. REPORTED EVENTS: 3487A LEAD (N=1)- PT EXPERIENCED A STAPHYLOCOCCUS AUREUS INFECTION THAT REQUIRED FLUCLOXACILLIN AND THE REPLACEMENT OF THE LEAD. NO ADD'L INFO CONCERNING PT SYMPTOMS AND OUTCOME WAS PROVIDE. UNK NEUROSTIMULATOR (N=1)- THE SPINAL CORD STIMULATION SYSTEM HAD TO BE REMOVED BECAUSE OF A STAPHYLOCOCCUS AUREUS INFECTION FROM THE PT SCRATCHING THEIR WOUNDS AND LEG ULCERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL CORD STIMULATION DEVICES GZB MEDTRONIC NEUROMODULATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR