BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXDRIVE

    MDR report key: 6530305 · Received April 28, 2017

    Report

    Report Number
    3007566237-2017-01642
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    April 26, 2017
    Report Date
    July 24, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    HAW
    UDI-DI
    00613994747853
    PMA / PMN Number
    K012366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: PRODUCT ID# MI-1000. ANALYSIS IDENTIFIED THAT THE MER COLLET WAS MALFORMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE ABOUT A PATIENT BEING IMPLANTED WITH DBS THERAPY FOR UNKNOWN SYMPTOMS. IT WAS REPORTED THAT DURING THE PATIENT¿S IMPLANT PROCEDURE THE MICRO ELECTRODE RECORDING (MER) COLLAR HAD A TIGHT HOLE THAT WOULD NOT ALLOW THE MER TO PASS THROUGH. THE IMPLANTING SURGEON USED A DIFFERENT MER COLLAR THAT COMES IN THE KIT TO FINISH THE SURGERY WITHOUT A PROBLEM. THERE WERE NO SYMPTOMS REPORTED. NO COMPLICATIONS OR FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312054 NEXDRIVE INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NEUROMODULATION MI-1000 082614116 00613994747853

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR