BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELIGEN

    MDR report key: 2060716 · Received April 18, 2011

    Report

    Report Number
    2124215-2011-06762
    Event Type
    Death
    Date Received
    April 18, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A FAMILY MEMBER ALLEGED THE PATIENT WITH THIS IMPLANTED DEVICE PASSED AWAY DUE TO BEING CONTINUOUSLY SHOCKED BY THE DEVICE. THE FAMILY MEMBER DID NOT KNOW IF THE PATIENT WAS EXPERIENCING AN ARRHYTHMIA, AND SAID THAT THE DEATH CERTIFICATE LISTED THE DEVICE AS A CAUSE OF DEATH. THE DEVICE REPORTEDLY WAS BURIED WITH THE PATIENT. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE CONTACTED THE PATIENT'S HEALTH CARE PROVIDER (HCP), WHO REPORTED THE PATIENT HAD BEEN LOST TO FOLLOW-UP. HCP REPORTED THAT THE PATIENT HAD NOT BEEN SEEN CLINICALLY IN 27 MONTHS AND HAD NOT CONDUCTED A REMOTE MONITORING INTERROGATION IN 22.5 MONTHS, AND THAT THEIR ATTEMPTS TO CONTACT THE PATIENT IN THE PAST HAD BEEN UNSUCCESSFUL.

    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 63 YR Death E110| 0125| 4470