BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2171624 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09937
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 IMPLANTED WITH THIS DEVICE SYSTEM REPORTING ENDURING SEVERAL SYNCOPAL EPISODES AND THAT HER PHYSICIAN WAS UNSURE WHAT WAS CAUSING THE EPISODES. A PATIENT ADVOCATE REPORTED THAT THE PATIENT WAS PRESENTED WITH HAVING A SEIZURE-LIKE ACTIVITY. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED UP TO 17 EPISODES OF ANTI-TACHYCARDIA PACING (ATP) PER DAY, AS WELL AS 16 TOTAL SHOCKS FROM THE DEVICE AND THAT AS A RESULT, THE DEVICE BATTERY WAS DEPLETING FAST. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, ADDITIONAL INFORMATION WAS UNAVAILABLE.

    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
    1 324 MO E110| 0184| 4470| 4136