BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173240 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10293
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 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 REPOSITIONED. FOLLOWING THE REVISION, ALL LEAD MEASUREMENTS WERE NORMAL AND THE PROBLEM WAS RESOLVED. 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 RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING LOSS OF CAPTURE AT MAXIMUM OUTPUT DURING A FOLLOW-UP AFTER THE IMPLANT PROCEDURE. NO CHANGES IN LEAD POSITION WERE NOTED ON X-RAY. THE PHYSICIAN STATED THE LEAD HELIX MAY NOT HAVE BEEN PROPERLY AFFIXED. NO SPECIFIC ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention