BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR

    MDR report key: 3801305 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10910
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 28, 2014
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF INCREASED PACING LEAD IMPEDANCE WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF LEAD IMPEDANCE TRENDS. THE REPORTED FIELD EVENT OF CAPTURE THRESHOLD ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE CAPTURE THRESHOLD ANOMALY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED LEAD NOISE EPISODES WERE OBSERVED VIA ELECTROGRAMS. NO NOISE WAS PRODUCED WITH ISOMETRICS. INCREASED PACING IMPEDANCE WAS ALSO OBSERVED ON THE VENTRICULAR LEAD. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279054 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention (B)(4)