BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELLIPSE VR

    MDR report key: 3080257 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-01000
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    March 21, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION INDICATE THERE IS NO SIGNIFICANT DIFFERENCE IN THE OCCURRENCE OF UNDERSENSING BETWEEN THE LOW FREQUENCY ATTENUATION (LFA) FILTER USED IN THESE DEVICES AND THE TACHY FILTER USED IN EARLIER GENERATION DEVICES. REVIEW OF STORED ELECTROGRAMS FROM SPECIFIC EPISODES CONTAINING UNDERSENSING DEMONSTRATES LOW AMPLITUDE SIGNALS THAT ARE NOT SENSED DUE TO AMPLITUDES BEING BELOW THE PROGRAMMED SENSITIVITY THRESHOLD OF THE DEVICE. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE PHYSICIAN DOES NOT HAVE ANY ALLEGATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF MERLIN. NET TRANSMISSION, SEVERAL VF AND NSLN EPISODES WERE RECORDED. UPON REVIEW OF THE EPISODES, IT APPEARED THAT VF WAS BEING TREATED APPROPRIATELY WHEN INTERMITTENT UNDERSENSING OF FINE VF OCCURRED. THE FINE VF WAS CLASSIFIED AS NSLN THEREFORE THERAPY WAS WITHHELD. TRANSMISSION WAS DONE AND THE FREEZE CAPTURE FROM TIME SHOWED PACING AND NO CAPTURE. IT WAS LATER REPORTED THAT THE PATIENT DIED AT SAME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182442 ELLIPSE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death (B)(4)