BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2153598 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06514
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 ONE DAY POST IMPLANT OF THE NEW DEVICE AND RIGHT VENTRICULAR (RV) LEAD, A FALSE VENTRICULAR SENSED (VS) EVENT WAS SEEN, RESULTING IN INHIBITED PACING. THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM WAS REPORTEDLY PACEMAKER DEPENDENT. TECHNICAL SERVICE DISCUSSED OBSERVATIONS AND RECOMMENDATIONS. THE DEVICE SENSITIVITY WAS REPROGRAMMED FROM 0.6MV TO 0.8MV AND ALL LEAD MEASUREMENTS WERE STABLE. THE PAUSES IN PACING WERE AGAIN OBSERVED. A CHEST XRAY WAS PERFORMED, HOWEVER, RESULTS WERE DEEMED TO BE WITHIN ACCEPTABLE LIMITS. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS PERFORMED WITH PROPER SENSING NOTED. DEVICE SENSITIVITY WAS PROGRAMMED TO MAXIMUM VALUE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    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 83 YR S603| 0185| 4135| 4456| E110