BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952246 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23829
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RECEIVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE LEAD HAS EXPERIENCED SHORTNESS OF BREATH, DIZZINESS AND LIGHT HEADEDNESS. AN ULTRASOUND WAS PERFORMED IN WHICH THIS LEAD APPEARED TO BE IN AN INAPPROPRIATE PLACE AND FULL OF TISSUE INGROWTH. CURRENTLY THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL PATIENT EFFECTS REPORTED.

    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 78 YR (B)(4)| (B)(4)| (B)(4)