BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4132144 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-17290
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 22, 2011
    Report Date
    July 17, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. 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 IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED CHRONIC HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THRESHOLD MEASUREMENTS WERE ALSO NOTED TO HAVE INCREASED. AN INVASIVE PROCEDURE WAS PERFORMED. IT APPEARED THAT THE HELIX MECHANISM HAD NOT BEEN FULLY EXTENDED AT THE INITIAL IMPLANT. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610251 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 1860| 0148| E102