BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR

    MDR report key: 3914529 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13114
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENTS OF HIGH PACING LEAD IMPEDANCE AND SENSING ANOMALIES WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A CONNECTOR ANOMALY. VISUAL INSPECTION IDENTIFIED EXCESS EPOXY IN THE V IS-1 BI SET SCREW BORE. THE EXCESS EPOXY PREVENTED THE V IS-1 BI SET SCREW FROM PROPERLY SECURING A LEAD AND RESULTED IN THE REPORTED FIELD EVENTS OF HIGH PACING LEAD IMPEDANCE AND SENSING ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEAD REPLACEMENT PROCEDURE, ONCE LEAD CONNECTION TO THE DEVICE WAS ESTABLISHED, HIGH, OUT OF RANGE PACING LEAD IMPEDANCE WAS OBSERVED. OVERSENSING AND UNDERSENSING WERE ALSO NOTED. PRIOR TO CONNECTION THE PACING LEAD IMPEDANCE WAS IN RANGE WHEN TESTED THROUGH PSA. MEASUREMENTS IN RANGE COULD NOT BE ESTABLISHED EVEN AFTER SEVERAL ATTEMPTS. THE PHYSICIAN SUSPECTED HEADER ISSUE. THE DEVICE WAS EXPLANTED AND REPLACED. THE POST PROCEDURE VALUES WERE WITHIN RANGE. THE PATIENT WAS FINE AND WAS DISCHARGED AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389805 ELLIPSE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR (B)(4)