BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 8781100 · Received July 11, 2019

    Report

    Report Number
    2017865-2019-10760
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 26, 2019
    Report Date
    October 15, 2019
    Manufacturer
    ABBOTT
    Product Code
    OJX
    UDI-DI
    05414734502603
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF PACING AND EPISODES OF OVERSENSING DUE TO ELECTROMAGNETIC INTERFERENCE WAS NOTED. THIS RESULTED IN THE PACEMAKER DEPENDENT PATIENT RECEIVING AN INAPPROPRIATE SHOCK. FURTHERMORE, HIGH OUT-OF-RANGE PACING IMPEDANCE VALUES WERE NOTED ON THE LEFT VENTRICULAR LEAD. LEAD REVISION IS ANTICIPATED. MANUFACTURER REPORTED NUMBER: 2938836-2019-05798.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATING THAT DURING THE LEAD REVISION, INSULATION DAMAGE WAS NOTED ON THE LEFT VENTRICULAR LEAD. THE LV LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES. MANUFACTURER REPORTED NUMBER: 2938836-2019-05798.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573269 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ABBOTT 1258T/75 3296341 05414734502603

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R UNIFY ASSURA ICD, CD3361-40C