BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3232038 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11224
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THIS LEAD REMAINS IN SERVICE WITHOUT ADDITIONAL COMPLICATION. 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 A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE PATIENT WAS SEEN IN CLINIC AND HIGH MEASUREMENTS WERE RECREATED WITH POCKET MANIPULATION. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS TESTED NUMEROUS TIMES WITH ACCEPTABLE MEASUREMENTS. THE DEVICE IMPLANTED WITH THIS LEAD WAS REPLACED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332628 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 4470| N119| 0184| MISMATCH