BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENERGEN

    MDR report key: 3790084 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-10091
    Event Type
    Death
    Date Received
    May 5, 2014
    Date of Event
    January 2, 2014
    Report Date
    April 7, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED A CALL FROM THE PATIENT'S SPOUSE STATING THE PATIENT PASSED AWAY APPROXIMATELY ONE MONTH AFTER HAVING THEIR SYSTEM EXPLANTED DUE TO AN INFECTION. THE PATIENT'S SPOUSE WAS UNWILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE INFECTION AND CAUSE OF DEATH. THE PATIENT'S CLINIC WAS CONTACTED FOR ADDITIONAL INFORMATION AND CONFIRMED THE PATIENT HAD VEGETATION ON THEIR LEADS. THE LEADS WERE EXPLANTED USING LASER EXTRACTION AND THE PULSE GENERATOR WAS REMOVED. THE CLINIC WAS NOT AWARE OF THE PATIENT'S DEATH, BUT DID NOTE THAT THE PATIENT DID NOT RECEIVE A REPLACEMENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268543 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| L H217| N141| 4135| 0184| 4554