BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1875016 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18486
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE DISPOSED OF BY THE HOSPITAL AND WILL NOT BE RETURNED. A NEW SYSTEM WAS SUCCESSFULLY IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), DEFIBRILLATION, AND TRANSVENOUS LEADS WERE EXPLANTED DUE TO A PATIENT INFECTION. THE PATIENT HAD DEVELOPED A CELLULITIS IN THEIR LEFT ARM CONTRIBUTING TO A POSSIBLE VEGETATION ON THE LEAD. NO FURTHER 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 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention E110| 4457| 1194| 0180| 4470