BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1950524 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22702
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 12, 2010
    Report Date
    November 29, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE UNDERWENT DETAILED ANALYSIS. VISUAL INSPECTION FOUND NO IRREGULARITIES. A REVIEW OF THE MEMORY LOG REVEALED THE DEVICE DID RECORD A LEADIMPLESSTHANMIN FOR THE SHOCK IMPEDANCE, A HIGH_VOLTAGE_SYSTEM_FAULT ALONG WITH A REPORTED SHOCK_LEAD_SHORT WHICH ALL OCCURRED ON (B)(6) 2010. ALSO NOTED WAS A CHARGE_TIME_OUT ON (B)(6) 2010. FURTHER, THE DAILY LEAD IMPEDANCE DATA WAS REVIEWED WHICH REVEALED NORMAL SHOCK IMPEDANCE MEASUREMENTS. LOW RIGHT VENTRICULAR IMPEDANCE MEASUREMENTS, ALTHOUGH WITHIN RANGE, WERE ALSO NOTED. THE DEVICE WAS X-RAYED WHICH REVEALED THAT THE PLASMA FUSE WAS OPEN. IN CONCLUSION, THIS PLASMA FUSE BECAME OPEN DUE TO A DAMAGED, SHORTED LEAD. SUBSEQUENTLY, END OF LIFE WAS DECLARED DUE TO A CHARGE TIME OUT AS A RESULT OF THE PLASMA FUSE CONDITION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND WAS RETURNED. DETAILED ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER 13 MONTHS OF IMPLANT A RED ALERT VIA LATITUDE WAS DETECTED NOTING LATITUDE WAS NO LONGER ABLE TO MONITOR THIS DEVICE DUE TO LIMITED BATTERY CAPACITY. IT WAS LATER REPORTED THAT THIS DEVICE EMITTED TONES AND HAD REACHED END OF LIFE (EOL). A SAVE TO DISK WAS PERFORMED. IN ADDITION, THERE WAS DISCUSSION PERTAINING TO A RED ALERT FOR LOW SHOCK IMPEDANCES WHICH WAS DETECTED DAYS BEFORE THE CHANGE OUT PROCEDURE. THIS OUT OF RANGE IMPEDANCE ALERT WAS DELIVERED THE SAME DAY AS THE ABOVE MENTIONED LATITUDE MONITORING RED ALERT. TECHNICAL SERVICES (TS) DISCUSSED ALERTS AND ADVISED THAT BOTH THE LEAD AND THE NEW ICD BE REPLACED. NO ADVERSE PATIENT EFFECTS WERE 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 47 YR Required Intervention E110| 0184| 4086| T127