BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951034 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-10703
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    February 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION CONFIRMED THE INSULATION WAS ABRADED EXPOSING THE CONDUCTOR COIL. THE DAMAGE WAS LOCATED APPROXIMATELY 26-27 CM FROM THE TERMINAL PIN. DUE TO THE NATURE AND LOCATION OF THE DAMAGE, IT WAS LIKELY DUE TO LEAD-ON-LEAD CONTACT. AS A RESULT, THE CLINICAL OBSERVATIONS WERE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WERE MANY EPISODES OF OVERSENSING RECORDED AS NON-SUSTAINED VENTRICULAR TACHYCARDIA ON THE RIGHT VENTRICULAR (RV) LEAD. ONE OF THE EPISODES CONTAINED ANTI-TACHYCARDIA PACING (ATP). AS A RESULT, THE LEAD WAS EXPLANTED. DURING THE REVISION PROCEDURE, INSULATION DAMAGE WAS NOTED NEAR THE SUTURE SLEEVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427891 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 0181| F102