BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3913535 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12758
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD COULD NOT BE INSERTED INTO A COMPETITOR'S DEVICE. THE PHYSICIAN DECIDED TO KEEP THE OLD DEVICE AND CREATED A NEW POCKET INSTEAD. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391842 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 0165| T177| F103| 0293