BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVENVM5 SYSTEM

    MDR report key: 6594233 · Received May 26, 2017

    Report

    Report Number
    2031966-2017-00054
    Event Type
    Death
    Date Received
    May 26, 2017
    Date of Event
    April 25, 2017
    Report Date
    May 25, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    PDQ
    PMA / PMN Number
    K152942
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED FOR EVALUATION. LITERATURE REVIEW: "CONTRAINDICATIONS, THE NVM5® SYSTEM MAY NOT BE EFFECTIVE, AND IS NOT INTENDED FOR USE, WHEN NEUROMUSCULAR BLOCK OR EPIDURAL BLOCKS HAVE BEEN USED FOR, OR IN CONJUNCTION WITH, ANESTHESIA. CONTRAINDICATIONS TO USE OF TRANSCRANIAL MOTOR EVOKED POTENTIAL (MEP) MONITORING INCLUDE EPILEPSY, CORTICAL LESIONS, CONVEXITY SKULL DEFECTS, RAISED INTRACRANIAL PRESSURE, CARDIAC DISEASE, PRO-CONVULSANT MEDICATIONS OR ANESTHETICS, INTRACRANIAL ELECTRODES, VASCULAR CLIPS OR SHUNTS, AND CARDIAC PACEMAKERS OR OTHER IMPLANTED BIOMEDICAL DEVICES. OTHERWISE UNEXPLAINED INTRAOPERATIVE SEIZURES AND POSSIBLY ARRHYTHMIAS ARE INDICATIONS TO ABORT MEP." "CONTRAINDICATION: DO NOT USE CUTANEOUS ELECTRODES FOR STIMULATION (STIMULATION ELECTRODES) IF THE PATIENT HAS A CARDIAC PACEMAKER, IMPLANTED DEFIBRILLATOR, OR OTHER IMPLANTED METALLIC OR ELECTRONIC DEVICE. SUCH USE COULD CAUSE ELECTRIC SHOCK, BURNS, ELECTRICAL INTERFERENCE, OR DEATH." "WARNING: PATIENTS WITH IMPLANTED ELECTRONIC DEVICES, SUCH AS CARDIAC PACEMAKERS, SHOULD NOT BE SUBJECTED TO ELECTRICAL STIMULATION UNLESS SPECIALIST MEDICAL OPINION HAS FIRST BEEN OBTAINED."

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING THAT ON (B)(6)2017, PATIENT UNDERWENT A DISCECTOMY INFUSION WITH POSTERIOR FIXATION REPORTEDLY WITH NO COMPLICATIONS. AS PER REPORTER PATIENT EXPIRED THAT NIGHT DUE TO ACUTE MYOCARDIAL INFARCTION. NO ALLEGATION OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375997 NUVASIVENVM5 SYSTEM NEUROSURGICAL NERVE LOCATOR PDQ NUVASIVE, INC. NVM5

    Patients

    Seq Age Sex Outcome Treatment
    1 Death