BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1945826 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20978
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND RV LEAD WERE EXPLANTED, AND THE PHYSICIAN PLANS TO IMPLANT A NEW SYSTEM IN SEVERAL WEEKS. THESE PRODUCTS WERE SENT TO THE HOSPITAL'S PATHOLOGY DEPARTMENT, AND LIKELY WILL NOT BE RETURNED TO BOSTON SCIENTIFIC. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SEVERAL WEEKS AFTER RECEIVING A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THIS PATIENT REPORTED FEELING A TINGLING SENSATION NEAR THE DEVICE. THE IMPLANT SITE HAD REPORTEDLY SWOLLEN UP AND BECAME HOT TO THE TOUCH. THE PATIENT WENT TO THE HOSPITAL AND WAS PLACED ON NEW ANTIBIOTICS. IT WAS LATER CONFIRMED THAT THE PATIENT HAD DEVELOPED AN INFECTION. OF NOTE, THE PATIENT'S SYSTEM INCLUDES A CHRONIC TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other 0158| E102| T177