BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3043381 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-04459
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 SOME SCRATCHES. THERE WAS NO EVIDENCE OF ARCING OBSERVED ON THE CASING. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, 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. THE FIELD DID CONFIRM A FRACTURED LEAD WHICH RESULTED IN THE HIGH VOLTAGE SYSTEM FAULT HAD OCCURRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REMAINS SURGICALLY ABANDONED WITHIN THE PATIENT. ANALYSIS OF THE DEVICE IS CURRENTLY BEING PERFORMED. THIS REPORT WILL BE UPDATED ONCE COMPLETED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT HAD RECEIVED INAPPROPRIATE SHOCKS FOR NOISE THAT OVERSENSED ON THE RIGHT VENTRICULAR (RV) LEAD. PATIENT WAS EVALUATED IN CLINIC POST SHOCKS. PACING IMPEDANCES MEASURING GREATER THAN 2000 OHMS AND SHOCKING IMPEDANCE MEASUREMENTS WERE GREATER THAN 200 OHMS ALONG WITH INCREASED THRESHOLDS WERE OBSERVED. UPON INTERROGATION A MESSAGE DISPLAYED STATING THE "SHOCK DELIVERED INTO AN OPEN CONDITION". THIS PATIENT IS NOT PACER DEPENDENT, SO THERE WERE NO ISSUES WITH CAPTURE. A LEAD REVISION OCCURRED THE FOLLOWING DAY TO REPLACE THE RIGHT VENTRICULAR (RV) LEAD DUE TO A FRACTURE FOUND ON X-RAY. DURING THE REVISION WHEN THE NEW RIGHT VENTRICULAR (RV) LEAD WAS CONNECTED TO THE ORIGINAL DEVICE DEFIBRILLATION THRESHOLD (DFT) TEST WAS IN PROCESS, A FAULT MESSAGE WAS OBSERVED. THERE WAS AN ATTEMPT TO PERFORM A MANUAL CAP REFORM, AT WHICH TIME THE DEVICE WENT INTO LIMITED DEVICE CAPACITY STATE. THE LOCAL FIELD REPRESENTATIVE CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WHO STATED THE LIMITED DEVICE CAPACITY IS THAT SHORTED CONDITION LIKELY SHORTED THE DEVICE. THE FAULT CODE DISPLAYED IS FOR A LONG CHARGE TIME (45 SEC). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT BOTH THE DEVICE AND LEAD SHOULD BE REPLACED DUE TO THE SHORTED CONDITION. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT, THE PHYSICIAN ELECTED TO REPLACE THE DEVICE HOWEVER, NOT THE NEW RIGHT VENTRICULAR (RV) LEAD. FOLLOWING DEFIBRILLATION THRESHOLD (DFT) TESTS THE LEAD TESTED APPROPRIATELY WITH THE REPLACEMENT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144716 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R 0157| T125| E143| E110| 6921L| 0185| MISMATCH| 4087