BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAINLESS STEEL DISC ELECTRODE

    MDR report key: 3133590 · Received May 24, 2013

    Report

    Report Number
    3008289288-2013-00007
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 24, 2013
    Manufacturer
    NATUS NEUROLOGY INCORPORATED
    Product Code
    IKT
    PMA / PMN Number
    K850108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOW AMPLITUDE SIGNAL IS A NON-SPECIFIC FINDING THAT MUST BE INTERPRETED BY THE PHYSICIAN WITH RESPECT TO THE PT'S COMPLAINTS, PHYSICAL FINDINGS, AND EMG TESTING PARAMETERS. PROPER EMG TEST PROTOCOLS MUST BE FOLLOWED TO ENSURE ACCURACY OF RESULTS. FALSE LOW AMPLITUDE SIGNALS EXPERIENCED DURING EMG MOTOR NERVE STUDIES MAY RESULT FROM IMPROPER ELECTRODE PLACEMENT, INADEQUATE SKIN PREPARATION, OR OTHER INAPPROPRIATE USE OF THE DEVICE, AS WELL AS FROM EQUIPMENT FAILURE. THIS COMPLAINT IS ASSOCIATED WITH EITHER THE "TWISTED LEAD 6030-TP" ELECTRODE OR THE "SEPARATE LEAD 6030-3-TP" ELECTRODE. IT IS NOT CLEAR FROM THE COMPLAINT WHICH ELECTRODE WAS INVOLVED. OUR ROOT CAUSE INVESTIGATION INDICATES THIS FAILURE MAY BE ASSOCIATED WITH A FAULTY CONNECTOR. ALL SIMILAR PRODUCT IN INVENTORY HAVE BEEN TESTED AND NO FAILURES WERE OBSERVED. A CAPA WAS ASSIGNED AND BASED ON THE ROOT CAUSE INVESTIGATION, A F/U REPORT WILL BE SUBMITTED FOR THIS MDR.

    Description of Event or Problem · 1

    DURING AN ELECTRODIAGNOSTIC EXAMINATION THE PHYSICIAN EXPERIENCED A LOW AMPLITUDE RESPONSE IN A MOTOR NERVE CONDUCTION STUDY. AS A RESULT, HE MISDIAGNOSED THE PT. THE NEXT DAY, THE SAME PHYSICIAN WAS CONDUCTING ANOTHER STUDY ON A DIFFERENT PT AND AGAIN EXPERIENCED A SIMILAR LOW AMPLITUDE RESULT. AT THAT POINT HE REALIZED THAT HE HAD MISDIAGNOSED THE PT THE DAY BEFORE. THE PT THAT WAS MISDIAGNOSED WAS NOTIFIED AND WAS BROUGHT BACK IN TO BE RETESTED. THE MISDIAGNOSIS RESULTED FROM A LOW AMPLITUDE VALUE RECORDED WHILE USING A REUSABLE STAINLESS STEEL DISC ELECTRODE WHEN CONDUCTING A MOTOR NERVE CONDUCTION STUDY. THIS COMPLAINT WAS RECEIVED ON (B)(6) 2013 AT WHICH TIME THE CUSTOMER INDICATED THE LOW AMPLITUDE WAS THE RESULT OF THE SYSTEM. WE WERE INITIALLY TOLD THAT THE ELECTRODE WAS NOT PURCHASED FROM NATUS. UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT THE SYSTEM WAS NOT AT FAULT AND THE ELECTRODE MAY HAVE BEEN THE ROOT CAUSE. WE ALSO LEARNED THAT THE ELECTRODE WAS A NATUS MODEL 6030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232497 STAINLESS STEEL DISC ELECTRODE REUSABLE DISK ELECTRODE IKT NATUS NEUROLOGY INCORPORATED 6030-TP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other