BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 5594376 · Received April 21, 2016

    Report

    Report Number
    1644487-2016-00849
    Event Type
    Injury
    Date Received
    April 21, 2016
    Date of Event
    March 30, 2016
    Report Date
    March 30, 2016
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VNS IMPLANT SURGERY ON (B)(6) 2016, WHEN THE SYSTEM DIAGNOSTIC TEST WAS RUN, THERE WAS CONSTANT MUSCLE CONTRACTION DURING THE WHOLE TEST. IT WAS REPORTED THAT THIS OCCURRED DURING THREE SYSTEM DIAGNOSTIC TESTS. UPON POST-OPERATIVE INTERROGATION, NO CONTRACTION WAS WITNESSED. PROGRAMMING HISTORY WAS PROVIDED TO THE MANUFACTURER FOR REVIEW. IT INDICATES THAT THE DEVICE WAS NOT TURNED ON YET. IT WAS PROGRAMMED AT 0MA OUTPUT CURRENT. SYSTEM DIAGNOSTIC TEST RETURNED IMPEDANCE RESULTS WITHIN NORMAL LIMITS WITH 2014 OHMS. FURTHER INFORMATION WAS RECEIVED, INDICATING THAT THE PATIENT WAS SEEN IN CLINIC AND THE DEVICE WAS SWITCHED ON TO 0.25MA OUTPUT CURRENT. NO PROBLEMS WITNESSED OR REPORTED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT BOTH, THE GENERATOR AND THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251420 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS 106 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR