BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043181 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02886
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY THE LEAD HAS NOT BEEN RECEIVED FOR ANALYSIS AND ATTEMPTS TO LOCATE THE LEAD HAVE BEEN UNSUCCESSFUL. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE EMERGENCY ROOM WITH HEART RATES IN THE 30S, THOUGH NO FALLS OR TRAUMA WERE REPORTED. A DEVICE EVALUATION WAS COMPLETED WHICH SHOWED NON-CAPTURE AND THRESHOLDS UP TO 5.5V AT 0.5MS. ALSO IMPEDANCE READINGS WERE > 2000 OHMS. UPON REVIEW OF THE DAILY MEASUREMENTS, IT WAS NOTED OVER THE PREVIOUS WEEK THE IMPEDANCES HAD RISEN TO 1700, THEN 1800 AND FINALLY > 2000 OHMS. IT WAS SUSPECTED THE LEAD WAS FRACTURED. SURGICAL INTERVENTION WAS PERFORMED AND THIS LEAD WAS EXPLANTED, AND AT THAT TIME, THE DEVICE WAS ELECTIVELY REPLACED AS IT WAS AT MIDDLE OF LIFE BATTERY LONGEVITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146505 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R H227| H170| 4542| 0185| 4470