BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1853691 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15059
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    June 2, 2010
    Report Date
    July 21, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN ELECTED TO ADD A NEW RATE/SENSE LEAD. DURING LEAD TESTING, THE LEAD SHORTED OUT. THE LEAD WAS CAPPED AND REPLACED WITHIN INCIDENT. AS THIS LEAD WAS SURGICALLY CAPPED AND ABANDONED, IT WILL NOT BE RETURNED FOR ANALYSIS AND, AS SUCH, THE ROOT CAUSE OF THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT NOISE WAS OVERSENSED ON THE RATE/SENSE PORTION OF THIS LEAD RESULTING IN INAPPROPRIATE ANTITACHYCARDIA PACING. ALL LEAD MEASUREMENTS WERE REPORTED TO BE STABLE AND WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 4469| T180| 0184