BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3053097 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05061
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. THE DEVICE WAS CONFIRMED TO BE IN SAFETY MODE. REVIEW OF STORED MEMORY VERIFIED THAT THE DEVICE EXPERIENCED THREE SYSTEM RESETS DURING THE TIME OF ELECTROCAUTERY USE, WHICH CAUSED THE DEVICE TO GO INTO SAFETY MODE. OF NOTE, THIS FAMILY OF DEVICES HAS BEEN SPECIFICALLY DESIGNED SUCH THAT IF THREE SYSTEM RESETS OCCUR WITHIN APPROXIMATELY 48 HOURS, A DEVICE WILL ENTER SAFETY MODE. THE BEHAVIOR OF THIS DEVICE IS CONSISTENT WITH DEVICES THAT HAVE REVERTED TO SAFETY MODE DUE TO ELECTROCAUTERY. DESIGN CHANGES HAVE NOW BEEN IMPLEMENTED TO ENHANCE THE ROBUSTNESS OF ELECTRIC CIRCUITS, SUCH THAT A DEVICE WOULD BE ABLE TO WITHSTAND THE RARE OCCURRENCES OF CONDUCTED ENERGY THAT PREVIOUSLY WOULD HAVE DISRUPTED CIRCUIT PERFORMANCE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ADMITTED DUE TO NOISE ON ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD. THE NOISE WAS OVERSENSED AND RESULTED IN INAPPROPRIATE SHOCKS. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. DURING THE PROCEDURE THE DEVICE WAS PROGRAMMED TO CAUTERY PROTECTION MODE. WHEN CAUTERY WAS APPLIED THE PATIENT JUMPED AS IF A SHOCK HAD BEEN DELIVERED. WHEN THE DEVICE WAS REMOVED FROM THE POCKET AND THE PATIENT RECEIVED ANOTHER SHOCK. THE ELECTROGRAM (EGM) HAD BEEN LOST FOLLOWING THE FIRST SHOCK AND WHEN THE DEVICE WAS REINTERROGATED IT WAS FOUND TO BE IN SAFETY CORE. THE RV LEAD WAS FOUND TO HAVE INSULATION DAMAGE NEAR THE SUTURE TIE DOWN SITE. THE ENTIRE SYSTEM WAS REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154597 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR E102| A155| 6949| MISMATCH