BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4140006 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17232
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RECENTLY WOKE UP AND FOUND HE WAS ON THE FLOOR, IT IS UNKNOWN IF THIS WAS SYNCOPE AS THE PATIENT WASN¿T SURE. THE PATIENT WAS THEN SEEN IN CLINIC AND AN INTERROGATION WAS DONE, WHICH NOTED THERE WAS NOTHING IN THE ARRHYTHMIA LOGBOOK AND THE DEVICE CHECKED OUT JUST FINE. THE DEVICE WAS SET TO AAI 40 BEATS PER MINUTE (BPM), THRESHOLDS WERE GOOD, THE PATIENT HAD SLOW CONDUCTION, SO IT IS UNKNOWN IF THE FALL WAS CARDIAC RELATED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED THAT SINCE THE PATIENT IS YOUNGER, SOME PROGRAMMING CHANGES COULD BE MADE AND CHANGING THE DEVICE PROGRAMMING TO DDD MODE WITH A LONG DELAY. THE PROGRAMMING WAS CHANGED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619585 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 10820 DA Hospitalization| L| R 0181| E110| 4086| 4469