BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041190 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01536
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS RETURNED SEVERED IN THREE SEGMENTS. SETSCREW MARKS WERE NOTED ON EACH OF THE SEGMENTS AND SEVERAL CUTS AND TEARS. IN ADDITION, THE RS- CONDUCTOR COIL WAS STRETCHED AND THE HELIX WAS EXTENDED, WHILE THE EXTRACTING STYLET WAS RETURNED STUCK IN THE LEAD. FINALLY, CALCIFICATION WAS NOTED ON THE TIP. DETAILED ANALYSIS REVEALED THAT THE TRILUMEN INSULATION WAS ABRADED AND THE RS- GORE APPEARED WORN AND TORN. THE LOCATION OF THE ABRASION AND THE TYPE OF DAMAGE (LONG AND FLAT) APPEARED TO HAVE MOST LIKELY BEEN CAUSED BY LEAD ON LEAD CONTACT OR POSSIBLY LEAD ON DEVICE INTERACTION. FURTHER ANALYSIS NOTED THAT THE RS CONDUCTOR COIL WAS FRACTURED UNDERNEATH AN AREA OF INSULATION ABRASION. THIS TYPE OF FRACTURE IS CONSISTENT WITH A FATIGUE FRACTURE. A FRACTURED RS- CONDUCTOR COIL COULD HAVE LED TO THE OBSERVATION OF OVERSENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECIEVED INFORMATION THAT A WARNING MESSSAGE APPEARED DUE TO OVERSENSING ON THIS RIGHT VENTRICUALAR LEAD. THIS LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS RETURNED AND ANALYSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143455 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1