BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042284 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01166
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IF NEW DETAILS ARE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, HIGH OUT OF RANGE PACING IMPEDANCES WERE EXHIBITED WITH THIS RIGHT VENTRICULAR LEAD. DAILY MEASUREMENTS CONFIRMED AN UPWARD TRENDING PATTERN FOR THE PAST SIX MONTHS. WHILE NO ADVERSE PATIENT EFFECTS WERE REPORTED, THE PHYSICIAN ELECTED TO SURGICALLY ABANDON THIS PRODUCT AND IMPLANT ANOTHER BOSTON SCIENTIFIC LEAD. NO COMPLICATIONS REPORTED DURING THE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention