BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELIGEN

    MDR report key: 2802717 · Received October 24, 2012

    Report

    Report Number
    2124215-2012-14460
    Event Type
    Death
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    November 28, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS OBTAINED THROUGH THE FIELD REPRESENTATIVE THAT THE PATIENT'S FAMILY REQUESTED THE DEVICE NOT BE RETURNED TO BOSTON SCIENTIFIC AT THIS TIME. THE PHYSICIAN WILL MAINTAIN POSSESSION OF THE DEVICE. AS THE DEVICE WILL NOT BE RETURNED, NO ANALYSIS CAN BE PERFORMED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT APPARENTLY COLLAPSED OUTSIDE OF A HOSPITAL SETTING AND PASSED AWAY. THE MEDICAL EXAMINER REQUESTED A DEVICE CHECK. WHEN THE FIELD REPRESENTATIVE ARRIVED AND CHECKED THE DEVICE, THE DEVICE WAS IN SAFETY MODE WITH A CHARGE FAULT MESSAGE AND THE DEVICE WAS NOT CAPABLE OF DELIVERING TACHY THERAPY. IT WAS NOTED THAT THE AUTOPSY HAD NOT YET BEEN PERFORMED BUT THE FIELD REPRESENTATIVE DID SEE A "Y" INCISION ON THE PATIENT'S CHEST AND WONDERED IF THE PATIENT COULD HAVE BEEN EXPOSED TO CAUTERY RECENTLY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED THAT EXPOSURE TO CAUTERY COULD CAUSE THE DEVICE TO GO INTO SAFETY MODE. ADDITIONAL INFORMATION WAS OBTAINED FROM THE FIELD REPRESENTATIVE THAT THE "Y" INCISION WAS MADE BY SCALPEL AT THE MEDICAL EXAMINERS (ME), AS THEY WERE GOING TO PROCEED WITH THE AUTOPSY HOWEVER DECIDED TO WAIT. THE FIELD REPRESENTATIVE DID NOTE IT WAS POSSIBLE THE LEAD MAY HAVE BEEN DAMAGED DURING THE ME MAKING THE INCISION. NO ELECTROCAUTERY WAS USED, BUT THE ME OFFICE DID STATE THE PATIENT MAY HAVE RECEIVED CARDIOVERSION IN THE AMBULANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 207 MO Death 4135| 0180| E110