BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052785 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04905
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    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

    A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO FURTHER PATIENT EFFECTS WERE REPORTED. 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 LEAD HAD A PACING IMPEDANCE MEASUREMENT GREATER THAN 3,000 OHMS. THE PACING THRESHOLDS WERE ALSO INCREASED. REVIEW OF DEVICE MEMORY SHOWED THE IMPEDANCE MEASUREMENTS HAD BEGUN TO INCREASE AROUND THE TIME THE PATIENT REPORTED HAVING FALLEN. A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION, THE LEAD WAS TESTED WITH A PACING SYSTEM ANALYZER (PSA). PSA MEASUREMENTS NOTED THE LEAD STILL HAD OUT OF RANGE IMPEDANCE, AND NO SENSING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention