BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

    MDR report key: 5009476 · Received August 17, 2015

    Report

    Report Number
    1045254-2015-00275
    Event Type
    Injury
    Date Received
    August 17, 2015
    Report Date
    July 21, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GXZ
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: (1) UNKNOWN NIM 3.0 SYSTE; (2) 2MM APS ELECTRODE ((B)(4)); 510K: K083124; (B)(4). THIS DEVICE IS BEING REPORTED FROM A LITERATURE REVIEW. NO DEVICES WILL BE RETURNED, THEREFORE NO EVALUATION COULD BE PERFORMED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FROM THE ARTICLE PUBLISHED IN THE "WORLD JOURNAL OF SURGERY" ON JULY 3, 2015 ENTITLED "CONTINUOUS VAGAL NERVE MONITORING IS DANGEROUS AND SHOULD NOT ROUTINELY BE DONE DURING THYROID SURGERY,�Y DAVID J. TERRIS; KATRINA CHAUNG; WILLIAM S. DUKE. THE ARTICLE DISCUSSED A NON-CONTROLLED TRIAL OF CONTINUOUS VAGAL NERVE MONITORING (CVNM). THE STUDY WAS CONDUCTED BETWEEN FEBRUARY 26, 2014 AND JUNE 25, 2014 ON 9 NON-RANDOMLY SELECTED PATIENTS UNDERGOING THYROID AND PARATHYROID SURGERY. IN EVENT 2 OUT OF 2 TOTAL EVENTS (EVENT 1 WILL BE REPORTED ON MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)), IT WAS REPORTED THAT EITHER A 2MM OR 3MM APS ELECTRODE WAS USED WITH THE MEDTRONIC NIM 3.0 SYSTEM WHEN THE APS ELECTRODE WAS "INADVERTENTLY AND TRAUMATICALLY DISLODGED, CAUSING VAGAL NEUROPRAXIA" INTRAOPERATIVELY. AS A RESULT, THERE WAS VISIBLE PERINEURAL ECCHYMOSIS OF THE VAGUS NERVE AND IMMEDIATE ATTEMPTS TO STIMULATE BOTH THE VAGUS NERVE AND RIGHT LARYNGEAL NERVE WERE UNSUCCESSFUL. IN THE POST-ANESTHESIA CARE UNIT, THE CORRESPONDING VOCAL FOLD WAS FOUND TO BE HYPOMOBILE UPON FLEXIBLE LARYNGOSCOPY. THE NERVE DYSFUNCTION RESOLVED 1 MONTH POSTOPERATIVELY AND THERE WAS NO REPORT OF PERMANENT PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541394 APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE ELECTRODE, NEEDLE GXZ MEDTRONIC XOMED INC. 8228053

    Patients

    Seq Age Sex Outcome Treatment
    1 Other