BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1851742 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14049
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS LEAD WAS PART OF A SYSTEM EXPLANT DUE TO DEVICE POCKET EROSION THAT RESULTED IN AN INFECTION. A REPLACEMENT DEVICE, RIGHT VENTRICULAR AND LEFT VENTRICULAR LEADS WERE SUCCESSFULLY IMPLANTED WITH NO ADVERSE EFFECTS. AN ATRIAL LEAD COULD NOT BE IMPLANTED BECAUSE THE PATIENT WAS IN ATRIAL FIBRILLATION AT THE TIME OF THE PROCEDURE AND THE PHYSICIAN WAS UNABLE TO IDENTIFY A STABLE POSITION WITH GOOD SENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 5568| 5068| 0175| H219| 4518