BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT LOW IMPEDANCE LEAD

    MDR report key: 1033621 · Received April 24, 2008

    Report

    Report Number
    6000153-2008-02199
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PT UNDERWENT A NEUROSTIMULATION TRIAL PROCEDURE WITHOUT COMPLICATIONS. THE DAY AFTER THE PROCEDURE, THE PT PRESENTED TO THE EMERGENCY ROOM WITH SEVERE BACK PAIN. AN MRI WAS DONE THAT SHOWED A LARGE SPINAL EPIDURAL HEMATOMA. THE EXACT LOCATION AND AMOUNT OF BLOOD WAS NOT REPORTED. SOME LOWER LEVEL PARALYSIS WAS REPORTED, BUT NOT CONFIRMED. THE PT WAS ADMITTED TO THE HOSPITAL AND THE NEUROSURGEON PERFORMED AN OPEN LAMINECTOMY TO RELIEVE PRESSURE ON THE SPINE THAT WAS RELATED TO BLEEDING. THE PT REMAINED HOSPITALIZED FOR THREE DAYS, THE PT'S PAIN HAD IMPROVED AND BY POST-OP DAY THREE THE PT WAS AMBULATORY WITH MILD BALANCE ISSUES BUT NO FALLS. AT DISCHARGE THERE WAS "NO FOCAL MOTOR WEAKNESS AND NO SENSORY CHANGES". REFER TO MFR REPORT #6000153200802198.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT LOW IMPEDANCE LEAD LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 3778 V087035005

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LOT # N138877| EXPLANTED| LOT # UNK IMPLANTED| EXTENSION MODEL 37081 LOT# NJB028717V IMPLANTED| ACCESSORY SNAP-LID CABLE MODEL 3550-31| EXTENSION MODEL 37081 LOT# NJB028715V IMPLANTED| EXPLANTED| EXTERNAL NEUROSTIMULATOR DEVICE MODEL 37021