BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO VR

    MDR report key: 2071226 · Received April 27, 2011

    Report

    Report Number
    2647346-2011-00618
    Event Type
    Death
    Date Received
    April 27, 2011
    Date of Event
    August 26, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE PATIENT IS INVOLVED IN A SETTLEMENT INVOLVING THE SPRINT FIDELIS LEADS. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL WITH ABDOMINAL PAIN, NAUSEA, VOMITING. TWO DAYS LATER THE PATIENT WAS FOUND IN PULSELESS ELECTRICAL ACTIVITY. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PATIENT DIED. FOLLOW UP WITH COMPANY FIELD REPRESENTATIVE RECALLS THE PHYSICIAN SAYING THE DEVICE INTERROGATION SHOWED SHOCKS DURING RESUSCITATION AND THE DEATH WAS LIKELY DUE TO A PULMONARY EMBOLUS. THERE WAS NEVER ANY DEVICE ALLEGATION BY THE PHYSICIAN. IT WAS LATER REPORTED BY AN ATTORNEY INDICATING THE PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| H| L| R