BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3212909 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09732
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS HAVING AN ABLATION PROCEDURE. INITIALLY THE FIELD REPRESENTATIVE TURNED THE TACHY THERAPY OFF AND NO CHANGES WERE MADE TO THE DDDR PACING MODE. HOWEVER, DURING THE PROCEDURE, THE DEVICE WAS INHIBITING PACING SO WAS REPROGRAMMED TO ASYNCHRONOUS PACING, BUT AGAIN PACING INHIBITION WAS OBSERVED. FINALLY, ELECTROCAUTERY MODE WAS PROGRAMMED ON AND NO FURTHER ISSUES WERE NOTED. THE FIELD REPRESENTATIVE DISCUSSED THE OBSERVATIONS WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND THE REASON THIS OCCURRED WAS DISCUSSED; THE IMPULSE FROM THE ABLATION PROCEDURE WAS OVERSENSED BY THE DEVICE AND IMPACTED PACING THERAPY TO THE PATIENT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT AND THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312772 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 0185| 4087| E110