BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2153555 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06296
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 15, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REGULAR FOLLOW-UP APPOINTMENT INDICATED THE DEVICE AND LEADS WERE FUNCTIONING APPROPRIATELY. THE RV LEAD PACING IMPEDANCE MEASUREMENTS WERE BETWEEN 1,800-2,000 OHMS. THE DAILY PACE/SENSE MEASUREMENTS WERE TURNED OFF AND THE PHYSICIAN PLANNED TO SEE THE PATIENT AT THE NEXT REGULAR FOLLOW-UP APPOINTMENT. 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 VIA LATITUDE REMOTE MONITORING THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. INTRINSIC SENSING AND PACING THRESHOLDS MEASUREMENTS WERE WITHIN NORMAL RANGE. THE PATIENT HAD A REGULAR FOLLOW-UP APPOINTMENT SCHEDULED IN THE NEAR FUTURE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS 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 67 YR 4017| 1861| E110| 0148