BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESUME

    MDR report key: 920871 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03044
    Event Type
    Injury
    Date Received
    September 21, 2007
    Report Date
    February 2, 2006
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD WAS IDENTIFIED AS RESUME ONLY, COULD BE MODEL 3587A (PROCODE GZF/GZB) OR PROCODE LGW). THIS REPORT IS BEING FILED UNDER EXEMPTION NUMBER E2007022. [SEE SCANNED PAGES]

    Description of Event or Problem · 1

    JOURNAL REFERENCE: FANZINI, A., P. FERROLI, ET AL. "HUGE EPIDURAL HEMATOMA AFTER SURGERY FOR SPINAL CORD STIMULATION." ACTA NEUROCHIRURGICA. 2005; 147(5): 565-7. PATIENT EXPERIENCED PARAPLEGIA POST SCS LEAD PLACEMENT. THE LITERATURE ARTICLE DISCUSSES INFO SUGGESTING A MALE PT BEING TREATED WITH SCS FOR PAIN EXPERIENCED PARAPLEGIA AND NUMBNESS POST SCS LEAD PLACEMENT. THE PARAPLEGIA WAS RELATED TO A LARGE EPIDURAL HEMATOMA. SURGICAL REMOVAL OF THE LARGE CLOT WAS PERFORMED IMMEDIATELY AND THE PT RETURNED TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUME GZF/GZB/LGW GZF MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R STIMULATOR| PROGRAMMER