BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1860546 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15137
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 4, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFUL IMPLANTED. A RETURN REQUEST WAS MADE FOR THE LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THIS ISSUE WAS DISCOVERED AS THIS LEAD HAD ELEVATED THRESHOLDS. UNDER FLUOROSCOPY, IT WAS NOTED THAT THIS LEAD HAD NOT DISLODGED BUT HAD LOST ITS SLACK.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE PRE-DISCHARGE DEVICE CHECK THIS DEFIBRILLATION LEAD HAD NOTED TO HAVE DISLODGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 71 YR Required Intervention 0184| MISMATCH| N119| 4469