BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2163300 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-08670
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES REPRESENTATIVE DISCUSSED SEVERAL STORED EPISODES ON THE SAVE TO DISK. NOISE WAS SEEN ON THE RIGHT VENTRICULAR PACE/SENSE AND SHOCK CHANNELS. THE NOISE APPEARS TO BE IRREGULAR AND INTERMITTENT. IN ADDITION SOME OVERSENSING WAS OBSERVED DUE TO NOISE. TECHNICAL SERVICES NOTED THAT PACING INHIBITION FOR > 2 SECONDS MAY HAVE OCCURRED DUE TO NOISE AND OVERSENSING. TECHNICAL SERVICES DISCUSSED SEVERAL INDICATIONS FOR NOISE SUCH AS LEAD AND DEVICE CONNECTION OR A POSSIBLE LEAD ON LEAD CONTACT RESULTING IN THE REPORTED CLINICAL OBSERVATION. ADDITIONAL INFORMATION PROVIDED NOTED THAT NO NOISE WAS SEEN SINCE IMPLANT AND NOISE WAS ONLY SEEN POST SHOCK. IN ADDITION IT WAS CONFIRMED BY A BOSTON SCIENTIFIC REPRESENTATIVE THAT THERE WAS NO LEAD ON LEAD CONTACT. A POSSIBLE LOOSE CONNECTION WAS SUSPECTED. ADDITIONAL INFORMATION PROVIDED NOTED THAT BOTH THE DEVICE AND LEAD WAS EXPLANTED AND REPLACED WITH COMPETITOR PRODUCTS. VISUAL INSPECTION OF THE DEVICE SHOWED BLOOD CONTAMINATION IN THE SETSCREW PORTION OF THE DEVICE. THE SYSTEM WILL BE RETURNED. UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4), A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. 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 WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS COULD NOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS AND THE DEVICE FUNCTIONED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A WHOLE COMPETITOR UNIT WAS EXPLANTED DUE TO A COMPETITOR LEAD RIGHT VENTRICULAR LEAD FRACTURE. THE COMPETITOR LEAD REMAINED IN THE RIGHT VENTRICLE. A NEW RIGHT VENTRICULAR LEAD AND DEVICE WERE IMPLANTED IN THE PATIENT. DURING DEFIBRILLATION TESTING NOISE WAS SEEN ON THE VENTRICULAR CHANNEL AFTER A SHOCK. THE NOISE SPORADICALLY DISAPPEARED AND WAS NO LONGER SEEN ON THE SHOCKING CHANNEL. IN ADDITION PACING IMPEDANCES HAD DECREASED. THE PHYSICIAN INQUIRED TO BOSTON SCIENTIFIC TECHNICAL SERVICES THE REASON THAT THE NOISE WAS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F103

    Patients

    Seq Age Sex Outcome Treatment
    1