BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780765 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13170
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN REPROGRAMMED THE LEAD TO THE LOWEST OUTPUT TO CONSERVE LONGEVITY, AND WILL BE ASSESSED AT THE NEXT FOLLOW UP. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER A RECENT AVN ABLATION PROCEDURE, THIS RIGHT VENTRICULAR LEAD WAS NOTED TO HAVE LOST CAPTURE DUE TO HIGH THRESHOLDS ALONG WITH PACING IMPEDANCES GREATER THAN 2000 OHMS. IT WAS SUSPECTED THAT DURING THE ABLATION PROCEDURE, RF SPIRALED DOWN THE LEAD AND ABLATED THE TISSUE TO LEAD INTERFACE. NO ASYSTOLE OR ADVERSE PATIENT EFFECTS WERE NOTED DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0171

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 4543| 0171| N051