BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1864231 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16219
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAD BACTERIEMIA AND THE LEAD WAS EXPLANTED. IT WAS NOTED THAT THE PATIENT HAS HAD MULTIPLE PIK LINES AND MULTIPLE HOSPITAL VISITS; THEREFORE, THE PHYSICIAN DOES NOT BELIEVE IT IS FROM THE SYSTEM. HOWEVER, THE EXPLANT FORM INDICATED THAT THE CAUSE OF THE INFECTION WAS UNKNOWN. IT WAS ALSO NOTED THAT THE PATIENT WAS NOT SYMPTOMATIC AND WAS NOT PACER DEPENDENT.

    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 69 YR Required Intervention 4480| 0175| E110