BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2913765 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00021
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 29, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION THAT THE PATIENT WITH THIS DEVICE EXPERIENCED A SYNCOPAL EPISODE. TWO DAYS LATER, THE PATIENT WAS SEEN FOR A DEVICE CHECK. THERE WERE NO ARRYTHMIAS IN THE LOGBOOK FOR THE DATE AND TIME OF THE SYNCOPE AND ALL MEASUREMENTS WERE APPROPRIATE. THE MONITOR ZONE AND THERAPY ZONES WERE REPROGRAMMED. THE PHYSICIAN SUSPECTED THE SYNCOPE WAS A RESULT OF HYPOTENSION AND STOMACH BLEED; HOWEVER, CANNOT RULE OUT ARRYTHMIAS SLOWER THAN THE LOWEST ZONE THAT WAS PROGRAMMED AT THE TIME OF THE EPISODE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20507 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E103

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening E103| 0295