BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951046 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-11225
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 4, 2013
    Report Date
    August 29, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. IT WAS NOTED THAT THE LEAD WAS SEVERED APPROXIMATELY 14 CENTIMETERS (CM) FROM THE TERMINAL PIN AND THAT ONLY THE PROXIMAL SECTION OF THE LEAD WAS RETURNED. SETSCREW MARKS WERE NOTED ON ALL TERMINAL CONNECTORS. A RESISTANCE TEST WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE WITH NORMAL MEASUREMENTS. DETAILED ANALYSIS REVEALED THAT THE INSULATION ON THE RATE-SENSE (RS) TERMINAL LEG WAS RUPTURED THROUGH WITH EVIDENCE OF ARCING DAMAGE ON THE CONDUCTOR APPROXIMATELY 8 CM FROM THE TERMINAL PIN. THIS DAMAGE WAS MOST LIKELY DUE TO LEAD-ON-CAN CONTACT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. THERE WAS NO OVERSENSING REPORTED AND NO ASYSTOLE OF MORE THAN TWO SECONDS. THE LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427895 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 0185| F102| 0175