BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO DR

    MDR report key: 1443260 · Received August 19, 2009

    Report

    Report Number
    2647346-2009-00410
    Event Type
    Death
    Date Received
    August 19, 2009
    Date of Event
    March 6, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED; THE CAUSE OF DEATH HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. EVALUATION SUMMARY: PRELIMINARY ANALYSIS REVEALED THE DEVICE HAD NO TELEMETRY AND NO OUTPUT, AND THE BATTERY WAS DEPLETED. FURTHER ANALYSIS REVEALED THAT ARCING HAD OCCURRED AT SEVERAL POINTS ON THE HYBRID. THIS RESULTED IN A HIGH CURRENT PATH THAT DEPLETED THE BATTERY. IT COULD NOT BE DETERMINED AT WHAT TIME THE ARCING OCCURRED. THE DEVICE WAS NOTED TO HAVE CATASTROPHIC DAMAGE IN SEVERAL COMPONENTS RELATED TO THE HIGH VOLTAGE DELIVERY CIRCUITRY. THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE CATASTROPHIC CONDITIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS EXPLANTED AFTER THE PATIENT'S DEATH AND COULD NOT BE INTERROGATED AT THE FUNERAL HOME; IT APPEARED THE BATTERY WAS COMPLETELY DEPLETED. IT WAS NOTED THAT THE INTERROGATION ATTEMPT OCCURRED SEVERAL DAYS AFTER THE PATIENT DIED, AND AFTER HE HAD BEEN EMBALMED. FOLLOW-UP INDICATES THAT THERE WERE NO DEVICE PERFORMANCE CONCERNS WHILE IMPLANTED. THE MANUFACTURER'S REPRESENTATIVE REPORTED A CARELINK REPORT FROM JANUARY 21, 2009 HAD SHOWN NORMAL DEVICE FUNCTION. THE PATIENT WAS SEEN IN THE CLINIC IN 2009, AND DEVICE INTERROGATION AT THAT TIME SHOWED NORMAL DEVICE FUNCTION. THE DEVICE WAS EXPLANTED, RETURNED TO THE MANUFACTURER AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other