BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2050263 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04097
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    December 22, 2010
    Report Date
    February 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPROGRAMMED FROM THREE ZONE TO TWO ZONES. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED A SHOCK FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. TECHNICAL SERVICES DISCUSSED THE EPISODE WAS DETECTED IN THE VENTRICULAR TACHYCARDIA 1 ZONE AND REDETECTED IN THE VENTRICULAR TACHYCARDIA ZONE. SINCE THE RHYTHM WAS IN REDETECTION THE DECISION TO TREAT WAS RATE-RELATED WITH NO DETECTION ENHANCEMENTS APPLIED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 64 YR 0157| 4087| E110| T135