BEUDAMED
    FDA Adverse Event Other Summary report: N

    TM-ECOCHGTRODE

    MDR report key: 1286757 · Received January 9, 2009

    Report

    Report Number
    1419887-2009-00001
    Event Type
    Other
    Date Received
    January 9, 2009
    Date of Event
    December 10, 2008
    Report Date
    January 9, 2009
    Manufacturer
    NATUS MEDICAL INC
    Product Code
    GXY
    PMA / PMN Number
    K944314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ELECTRODE WAS RETURNED FOR EVALUATION. CUSTOMER HAD STATED THAT THERE WAS EXPOSED METAL ON THE TIP OF THE ELECTRODE. THIS WAS CONFIRMED. VISUAL INSPECTION OF THE ELECTRODE SHOWED THAT THE ELECTRODE SILVER WIRE (SHAPED INTO A DIAMOND TO PREVENT EDGES FROM PROTRUDING) WAS EXPOSED ON ONE SIDE (NOT TOWARD THE DISTAL END). THE OVERALL CONDITION OF THE HYDROGEL COVERING WAS GOOD BUT SEEMED TO BE SMOOTHER THAN NORMAL AND VERY CLEAN, MOST LIKELY DUE TO USE WITH CONDUCTIVITY GEL AND DRYING AFTERWARD. THE EXPOSED PORTION OF WIRE IS NOT SHARP OR POINTED. THE HYDROGEL COVERING IS FOR EXTRA CUSHIONING AND AN INCREASED SURFACE AREA. METAL TO TYMPANIC MEMBRANE (TM) CONTACT HAS NO EFFECT ON THE SAFETY OR PERFORMANCE. THE PREDICATE DEVICE USED BARE METAL INSTEAD OF HYDROGEL. TO ACHIEVE A HOLE IN THE TM, THE ELECTRODE MUST BE MECHANICALLY PUSHED THROUGH THE TM, OR AS STATED BY THE CUSTOMER, "BURNED." AS PART OF THE CORRESPONDENCE FOR 510K K944314, IT WAS STATED THAT THE MAXIMUM PRESSURE ACHIEVED BY HOLDING THE ELECTRODE AT 1.5 INCHES FROM THE TIP (THE AVERAGE DEPTH OF AN EAR CANAL), RESULTING IN A 1.66 PSI FORCE, MUCH LESS THAN THE 25 PSI DESCRIBED IN LARYNGOSCOPE 68: 2015-2027, 1958. VISUAL INSPECTION OF THE HYDROGEL TIP SHOWS NO SIGN OF DEGRADATION (MELTING, DISCOLORATION, CHARRING) TYPICALLY EXPECTED FROM A HIGH ENERGY TRANSFER THROUGH OR NEAR THE HYDROGEL SUFFICIENT TO "BURN" TISSUE. THE FACILITY IS USING A NAVIGATOR E SYSTEM PURCHASED IN 2002. WHEN ASKED TO RETURN THE UNIT FOR EVALUATION, THE CUSTOMER DECLINED. FROM THE VISUAL INSPECTION AND LACK OF INSTRUMENT EXAMINATION, THIS EVALUATION CONCLUDES THAT THE PT TM WAS NOT DAMAGED MECHANICALLY OR ELECTRICALLY FROM CONTACT WITH THE DEVICE.

    Description of Event or Problem · 1

    THE PT [(B)(6) MALE] HAS A SEVERE SENSORI-NEURAL HEARING LOSS ON THE LEFT SIDE AND THEY WERE PERFORMING ECOCHG BECAUSE THEY WERE SUSPECTING MENIERES. THE NURSE PRACTITIONER INSERTED THE TMTRODE INTO THE EAR, AFTER CLEANING IT OUT WITH SALINE, AND THEN VISUALIZED THE EAR CANAL AND EARDRUM USING A SURGICAL MICROSCOPE, SUCTIONING OUT THE REMAINING SALINE. PT DID NOT COMPLAIN OF 'PAIN' WHEN THEY INSERTED THE TM BUT CUSTOMER STATED MOST OF THEIR PTS DO. THEY HAD PLACED THE TMTRODE IN POSITION ON THE PT'S EARDRUM AND TRIED TO TEST. THE PT COMPLAINED OF PAIN WHEN REMOVING THE ELECTRODE. IT LEFT A HOLE IN THE EARDRUM 3 X 2MM THAT LOOKED LIKE A 'BURN', ACCORDING TO THE PHYSICIAN. THE PT IS NOT HAPPY ACCORDING TO THE DOCTOR. HE HAS PUT A 'SALOS' PATCH ON IT AND ADMINISTERED PREDNISONE AND AN ANTIBIOTIC. HE ESTIMATES IT WILL TAKE 6 WEEKS TO HEAL. IT HAS CREATED A MILD TO MODERATE SENSORI-NEURAL HEARING LOSS ACCORDING TO THE DOCTOR. HE WILL BE SEEING THE PT ONCE A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM-ECOCHGTRODE TM ELECTRODE GXY NATUS MEDICAL INC 101125 81270-0

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other LECTRON II CONDUCTIVE GEL| NAVIGATOR E SYSTEM # 02J0511