BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1873829 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17512
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED AND IS UNDERGOING DETAILED LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING WAS PERFORMED ON ALL PORTS WITH NO ISSUES NOTED. THE DEVICE WAS PROGRAMMED TO DDD PACING MODE AND ATRIAL AND RIGHT VENTRICULAR PACING WAS CONFIRMED AT 60 BPM. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE CLINICAL OBSERVATIONS OF NO PACING OUTPUT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE DEVICE HAS NOT BEEN RECEIVED. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AN ATTEMPTED IMPLANT. UPON CONNECTION TO THE CHRONIC LEADS, NO PACING OUTPUT WAS OBSERVED AND THE PATIENT EXPERIENCED ASYSTOLE. SEVERAL ATTEMPTS WERE MADE TO RESOLVE THIS, BUT DUE TO THE ASYSTOLE, TRANSCUTANEOUS PACING WAS REQUIRED AND A NEW DEVICE OF THE SAME MODEL WAS IMPLANTED. THE FIELD REPRESENTATIVE BELIEVED THE LACK OF PACING MAY HAVE BEEN A CONNECTION ISSUE, BUT THERE WAS NO TIME TO INVESTIGATE FURTHER. THE NEW DEVICE AND CHRONIC LEADS HAD GOOD PACING OUTPUTS AND LEAD MEASUREMENTS. THE EXPLANTED DEVICE WILL BE RETURNED FOR LABORATORY ANALYSIS.

    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 63 YR Life Threatening T127| 0158| 4471| 4470| 1297