BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052785 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05591
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEAD WERE SUCCESSFULLY EXPLANTED AND REPLACED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS CONFIRMED THE INNER CONDUCTOR COIL WAS FRACTURED 20 CENTIMETERS (CM) FROM THE TERMINAL PIN. DETAILED ANALYSIS OF THE FRACTURE SITE DETERMINED THE CONDUCTOR COIL WAS FRACTURED DUE TO CYCLIC FATIGUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE. THE NOISE WAS OVERSENSED RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND MULTIPLE SHOCKS. THE NOISE WAS ABLE TO BE REPRODUCED WITH MANIPULATION OF THE DEVICE HEADER. THE LOCAL FIELD REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND INQUIRED ABOUT ADVISORY STATUS OF THE DEVICE. TS DISCUSSED THAT THIS DEVICE IS INCLUDED IN THE (B)(6) 2009 SUBPECTORAL IMPLANT 2009 ADVISORY POPULATION. THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE DEVICE WAS NOT IMPLANTED SUBPECTORAL. AN INVASIVE PROCEDURE WAS PERFORMED. THE POCKET WAS OPENED AND A FRACTURE WAS OBSERVED IN THE LEAD. NOISE WAS PRODUCED WHEN THE LEAD WAS MANIPULATED NEAR THE FRACTURE AND ALSO NEAR THE DEVICE HEADER. A HEADER ISSUE WAS UNABLE TO BE RULED OUT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155651 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 4549| 0185| N119| 4474| 4195