BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE ST VR

    MDR report key: 4210687 · Received October 29, 2014

    Report

    Report Number
    2938836-2014-17204
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY AND WAS CAUSED BY A POWER-ON RESET. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT AND THE HV OUTPUT CIRCUIT WAS FOUND TO BE DAMAGED. THE CAUSE OF THE DAMAGED HV OUTPUT CIRCUIT AND POWER-ON RESET COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A VT ABLATION. THE PHYSICIAN REPORTED THAT THE DEVICE DELIVERED THERAPY SUCCESSFULLY DURING THE ABLATION. THREE HOURS POST ABLATION, THE PATIENT WENT INTO A VF ELECTRICAL STORM. THE DEVICE SUCCESSFULLY SHOCKED AND TERMINATED THE VF, BUT SEVERAL MINUTES LATER, THE VF STORM CONTINUED AND SHOCKS WERE NOT SUCCESSFUL. THE RHYTHM WAS TERMINATED WITH EXTERNAL DEFIBRILLATION. THE NEXT DAY, DEVICE INTERROGATION REVEALED BACK-UP VVI MODE. IT WAS NOT KNOWN WHAT CAUSED THE BACK-UP VVI MODE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693668 ELLIPSE ST VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1277-36 NA

    Patients

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