BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICTORY XL SR

    MDR report key: 1822912 · Received September 1, 2010

    Report

    Report Number
    2017865-2010-03180
    Event Type
    Death
    Date Received
    September 1, 2010
    Date of Event
    May 6, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4) : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ALLEGEDLY, AT THE CONCLUSION OF A LITHOTRIPSY PROCEDURE IT WAS NOTED THAT THE PT WAS NOT REVIVING. THEY INITIATED A CODE BLUE BUT HOSPITAL PERSONNEL WERE UNABLE TO REVIVE PT; HE EXPIRED. THE PT HAD A PRE-EXISTING CONDITION OF SEVERE HEART DISEASE; THIS WAS ADDRESSED WITH THE IMPLANTATION OF A PACEMAKER 2 YEARS PRIOR TO THIS EVENT. THE FAMILY DECLINED AN AUTOPSY, SO THE HOSPITAL COULD NOT DRAW AN ABSOLUTE CONCLUSION ON WHAT OCCURRED, BUT THEY BELIEVE THAT HE SUFFERED A MYOCARDIAL INFARCTION WHILE ON THE TABLE AND THAT A COMBINATION OF THE AGE OF THE PT AND PRE-EXISTING HEART CONDITION CAUSED THE HEART ATTACK. LITHOTRIPSY UNIT FUNCTIONED WELL; HOSPITAL DID NOT BELIEVE IT WAS A FACTOR IN DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6)2010. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICTORY XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5610 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death