BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2911801 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17073
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 26, 2012
    Report Date
    January 11, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. DUE TO THE LOOSE HEADER, THE DEVICE ARCED UNDER THE HEADER TO THE CASE CAUSING THE SHORTED LEAD FAULT AND THE LOW SHOCK IMPEDANCE. THERE WERE SOME MARKS ON THE HEADER, BUT IT APPEARED THE HEADER WAS LOOSE PRIOR TO EXPLANT BUT WAS LIFTED FURTHER DURING THE EXPLANT PROCEDURE. BASED ON THE MEMORY LOG, THE SHORTED LEAD EPISODE AND THE ARCING OF THE DEVICE WERE INDUCED DURING THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THROUGH A REMOTE MONITORING SYSTEM THAT THE VENTRICULAR TACHYCARDIA MODE WAS PROGRAMMED TO A VALUE OTHER THAN MONITOR AND THERAPY. IT WAS NOTED THAT THE PROGRAMMING WAS INTENTIONAL UNTIL A LEAD REVISION COULD BE PERFORMED DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. INFORMATION WAS SUBSEQUENTLY RECEIVED AFTER THE RV LEAD WAS EXPLANTED AND REPLACED, DEFIBRILLATION THRESHOLD (DFT) TESTING WITH THE NEW RV LEAD WAS UNSUCCESSFUL. AN EXTERNAL SHOCK WAS PROVIDED TO GET THE PATIENT OUT OF VENTRICULAR FIBRILLATION (VF). DURING THE INDUCTION, TELEMETRY WAS LOST AND THERE WAS A MESSAGE REGARDING SHORT CIRCUIT CONDITION DUE TO SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. WHEN THE DEVICE WAS REMOVED FROM THE POCKET, THE HEADER APPEARED TO MOVE FREELY WITH BLOOD COMING OUT OF IT. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17030 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R E102| 0185