BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE VR

    MDR report key: 4760313 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04602
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    March 2, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF HIGH PACING LEAD IMPEDANCE, NOISE, AND HIGH CAPTURE THRESHOLDS WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND AN ANOMALOUS TRANSISTOR WAS OBSERVED. THE CAUSE OF THE FIELD EVENT WAS DUE TO AN ANOMALOUS TRANSISTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC WITH HIGH, OUT OF RANGE, PACING LEAD IMPEDANCE. NOISE, CAPTURE ANOMALY WITH HIGH PACING THRESHOLD, AND SENSING ANOMALY WERE NOTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS FINE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305265 ELLIPSE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1411-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention