BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2173875 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11418
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF BOSTON SCIENTIFIC'S COMPLAINT HANDLING DATABASE DID NOT REVEAL ANY CALLS OR ISSUES THAT HAVE BEEN REPORTED FOR THIS PATIENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT PASSED AWAY FOURTEEN MONTHS LATER. ACCORDING TO AN ONLINE OBITUARY SEARCH, THE PATIENT PASSED AWAY AT A HOSPITAL FOLLOWING A LENGTHY ILLNESS. THERE WERE NO REPORTED ALLEGATIONS AT THE TIME OR TO THIS DATE THAT THE DEVICE OR PREVIOUS EVENTS CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. 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 INFORMATION THAT THIS PATIENT HAD UNDERGONE BYPASS SURGERY TWO DAYS AGO AND THIS MORNING HIS HEART RATE WAS IN THE 40'S AND THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST. THE CALLER STATED THAT THE PHYSICIANS AT THIS HOSPITAL DO NOT PROGRAM THE DEVICE AND SHE WAS INQUIRING IF THERE WAS ANY RECORD OF THE DEVICE BEING TURNED BACK ON FOLLOWING THE BYPASS SURGERY. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT EXPLAINED TO THE CALLER THAT THE PHYSICIANS CAN REQUEST A REPRESENTATIVE TO HELP WITH DEVICE PROGRAMMING. HOWEVER, THIS INFORMATION IS NOT ALWAYS DOCUMENTED BY THE REPRESENTATIVE. THE CALLER STATED THAT THE PATIENT IS NOW ON A VENTILATOR WITH NO NEUROLOGICAL RESPONSE AND IS BEING EXTERNALLY PACED.

    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 68 YR Life Threatening A155| 4470| 0147| E110