BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3050764 · Received April 10, 2013

    Report

    Report Number
    3007566237-2013-01194
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE OPERATING ROOM TO REPLACE A DEPLETED INS WITH A NEW 37714. IMPEDANCES OVER 40,000 OHMS WERE SEEN ON ALL ELECTRODES ON THE BOTTOM PORT, 8-15, FROM THE DEFAULT VOLTAGE ALL THE WAY UP TO 3V.IT WAS NOTED THAT THE PREVIOUS INS HAD BEEN DEAD, SO IT WAS NOT POSSIBLE TO TEST IMPEDANCES PRIOR TO SURGERY. THE LEAD WAS TESTED SEPARATELY IN A MULTI-LEAD TRIALING CABLE AND ALL IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL RANGE. THE CONNECTOR BLOCK OF THE INS DIDNOT LOOK LIKE IT HAD FLUID IN IT. THE HCP TRIED APPROXIMATELY FIVE TIMES TO DISCONNECT AND RECONNECT THE LEADS FROM THE INS WITHOUTSUCCESS. IT WAS NOTED THE HCP ALSO TRIED TO SUCTION THE CONNECTOR PORT OF THE INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153024 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37714

    Patients

    Seq Age Sex Outcome Treatment
    1