BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910658 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15508
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SURGICALLY ABANDONED. 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 THIS RIGHT VENTRICULAR LEAD DISPLAYED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. AN XRAY REVEALED A LEAD FRACTURE. AN ADDITIONAL PACE/SENSE LEAD WAS CONNECTED TO THE DEVICE. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18920 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0161

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R