BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1874022 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19694
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACING SYSTEM HAS BEEN RECEIVED AT BOSTON SCIENTIFIC CRM AND ARCHIVED. DESPITE THE FACT THAT BOSTON SCIENTIFIC CRM FOLLOWS STRICT PROCEDURES TO ENSURE ALL OF OUR IMPLANTABLE DEVICES ARE COMPLETELY STERILE PRIOR TO IMPLANT AND PROVIDES RECOMMENDATIONS FOR HANDLING THE STERILE PACKAGING PRIOR TO IMPLANTATION, IT IS IMPOSSIBLE TO ELIMINATE ALL RISK OF INFECTION IN A SURGICAL SETTING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND LEADS DEVELOPED REDNESS AND A WARM FEELING AROUND THE DEVICE POCKET. THE PATIENT SHAVES HIS CHEST REGULARLY AND IT WAS SUSPECTED THIS HAD LEAD TO A POCKET INFECTION. A REPLACEMENT PROCEDURE WAS PERFORMED. THE DEVICE AND LEADS WERE EXPLANTED. THE DEVICE AND ATRIAL LEAD WERE COMPLETELY REMOVED. THE RIGHT VENTRICULAR LEAD WAS PULLED OUT UNTIL IT BECAME STUCK IN THE RIGHT VENTRICLE. AT THAT POINT, THE LEAD WAS SURGICALLY ABANDONED. ALL PRODUCTS REMOVED WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening 4087| E110| 0185