BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771616 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13391
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 15, 2024
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WILL BE SENT FOR FURTHER EVALUATION AND POSSIBLE LEAD REVISION/EXTRACTION. THE LOCAL AREA REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION HOWEVER NO FURTHER INFORMATION WAS AVAILABLE. AS OF TODAY, ALL AVAILABLE INFORMATION INDICATES THAT THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD EXHIBITED HIGH, OUT OF RANGE SHOCK IMPEDANCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female 0184| 1297| 4456| 4469| 5568| T125| 0184| T125| 4469| 1297| 4456| 5568