BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2905472 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-14000
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTRICULAR SENSITIVITY WAS REPROGRAMMED TO RESOLVE THE OVERSENSING. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED OVERSENSING OF ATRIAL EVENTS ON THE VENTRICULAR CHANNEL. INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES AND NONSUSTAINED VENTRICULAR TACHYCARDIA EPISODES WERE STORED DUE TO THE OVERSENSING. IT WAS REPORTED PACING WAS INHIBITED FOR ONE TO THREE SECONDS WHEN THE DEVICE WAS IN AN ATR EPISODE. IT WAS REPORTED THE PATIENT IS PACER DEPENDENT. NO ADVERSE PATIENT EFFECTS OR SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11899 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention E110| T135| 0185| 4470| T125