BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL SR

    MDR report key: 9208309 · Received October 18, 2019

    Report

    Report Number
    2017865-2019-15267
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    October 5, 2019
    Report Date
    March 30, 2020
    Manufacturer
    ABBOTT
    Product Code
    NVZ
    UDI-DI
    05414734505987
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH NO TELEMETRY, NO OUTPUT, AND BATTERY VOLTAGE BELOW THE END OF SERVICE (EOS) LEVEL. ANALYSIS OF THE DEVICE IMAGE FOUND THE BACKUP VVI MODE WAS TRIGGERED DUE TO LOW BATTERY FLUCTUATIONS. LONGEVITY ASSESSMENT FOUND THE DEVICE WAS IMPLANTED BEYOND ITS PROJECTED LONGEVITY AND BATTERY DEPLETION TO EOS WAS NORMAL. AFTER REPLACING THE BATTERY AND RELOADING THE PRODUCT CODE, NORMAL TELEMETRY WAS ESTABLISHED. SUBSEQUENT ELECTRICAL TESTS PERFORMED ON THE DEVICE DID NOT IDENTIFY ANY ANOMALIES.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS NOTED TO BE IN BACKUP MODE. TECHNICAL SUPPORT WAS CONTACTED BUT COULD NOT RETRIEVE DEVICE IMAGES, THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003815 ZEPHYR XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR NVZ ABBOTT 5626 3094524 05414734505987

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R