BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2173665 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-12176
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) UNDERWENT OPEN HEART SURGERY. FOLLOWING THIS PROCEDURE, THE RIGHT ATRIAL (RA) LEAD WAS NOT SENSING APPROPRIATELY. THERE WAS INTERMITTENT VENTRICULAR CAPTURE AT 5 VOLTS AND THE DEVICE MARKED ALL VENTRICULAR EVENTS AS PREMATURE VENTRICULAR CONTRACTIONS (PVCS). WHEN THE DEVICE PACED, IT PACES INTO THE QRS COMPLEX, POSSIBLY INTO THE T-WAVE. THE PATIENT HAD A TEMPORARY WIRE PLACED AND THE PHYSICIAN HAS REQUESTED THE DEVICE BE PROGRAMMED OFF. TECHNICAL SERVICES (TS) SUGGESTED THE PACER BE PROGRAMMED OFF SINCE THE PATIENT IS BEING PACED BY A TEMPORARY PACER, PACING THERAPY WILL CONTINUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THE RA LEAD WAS A COMPETITOR'S LEAD. THERE WAS NO PACING INHIBITION OR ASYSTOLE GREATER THAN TWO SECONDS.

    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 76 YR MISMATCH| 0185| E110