BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIC PLUS DR

    MDR report key: 1955226 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00566
    Event Type
    Death
    Date Received
    January 10, 2011
    Date of Event
    November 8, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT INTERROGATE. THE PATIENT WAS LAST SEEN SINCE IMPLANT. THE DEVICE WAS NOT PACING ON A SURFACE ECG, AND THE BATTERY IS SUSPECTED TO BE COMPLETELY DEPLETED. THE DEVICE WILL BE EXPLANTED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED ON (B)(6) 2011 THAT THE PATIENT EXPIRED. CAUSE OF DEATH WAS UNKNOWN. THE PATIENT WAS IN HOSPICE AT THE TIME OF THE EVENT. THERE WAS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WA S DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-236 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death