BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXDRIVE

    MDR report key: 4577686 · Received March 6, 2015

    Report

    Report Number
    3007566237-2015-00544
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Report Date
    February 11, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    HAW
    PMA / PMN Number
    K012366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE WAS UPDATED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEXFRAME MER COLLET FOUND THE MER COLLET MALFORMED, NEW OUT OF BOX.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICROELECTRODE WOULD NOT COME OUT, EVEN WHEN THE SCREW WAS TAKEN OUT. THIS HAD OCCURRED DURING THE PROCEDURE ON THE DATE OF THIS REPORT. A DIFFERENT PRODUCT WAS USED. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS REQUIRED. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AND THE CAUSE WAS NOT DETERMINED. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE PATIENT WAS DOING FINE AND HAD NOT BEEN AFFECTED BY THIS. AFTER THE HEALTHCARE PROFESSIONAL HAD REMOVED THE CARRIER IT APPEARED THE ELECTRODE MAY HAVE BEEN STUCK TO THE MER CANNULA RATHER THAN THE ELECTRODE CARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157259 NEXDRIVE INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NEUROMODULATION MI-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR