BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    MDR report key: 5803643 · Received July 19, 2016

    Report

    Report Number
    1045254-2016-00235
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 21, 2016
    Report Date
    June 22, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: TRIVANTAGE 8229707 , LOT NO: 0211132850, 510K: K112686. THE DEVICES HAVE NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, BOTH DEVICES WERE RECEIVED FOR EVALUATION (DETAILED AS FOLLOWS): BOTH DEVICES HAD NO EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE LACK OF REACTIVITY WITH HYDROGEN PEROXIDE] AND APPEARED VERY CLEAN...HOWEVER ONE DEVICE WAS MISSING THE TRACHEAL TUBE ADAPTER. THERE WERE NO ANOMALIES OBSERVED VISUALLY WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT, HOWEVER WHEN EACH TUBE WAS INFLATED WITH 20 ML AIR, THE CUFFS DID NOT REMAIN INFLATED. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS A RAGGED TEAR IN EACH CUFF, APPROXIMATELY IN THE SAME LOCATION. THE MOST LIKELY ROOT CAUSE FOR THESE CUFF TEARS IS THE CUFF APPEARS TO HAVE SNAGGED ON A SHARP INSTRUMENT OR PATIENT DENTAL APPLIANCE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PARATHYROIDECTOMY, THE INFLATION CUFF OF THE EMG ENDOTRACHEAL TUBE LEAKED AFTER INTUBATION. THE TUBE HAD BEEN CHECKED AND INFLATED NORMALLY PRIOR TO INTUBATION. THE PATIENT WAS REINTUBATED WITH A SECOND TUBE, WHICH WAS ALSO TESTED PRIOR TO USE. THIS SECOND TUBE LEAKED AS WELL, AND AGAIN, WAS REPLACED. THERE WAS NO OTHER MEDICAL INTERVENTION NEEDED, AND THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457995 NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE® STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229708 0207924147

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR