BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140453 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17564
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 25, 2014
    Report Date
    November 6, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. MICROSCOPIC INSPECTION NOTED TRILUMEN INSULATION DAMAGE THROUGH TO THE RATE SENSE LUMEN APPROXIMATELY 265-280MM FROM THE TERMINAL PIN. THE TRILUMEN INSULATION HAD WEBBING DAMAGE IN THIS AREA BETWEEN THE RATE SENSE, DISTAL AND PROXIMAL HIGH VOLTAGE LUMENS. THE INSULATION WAS FLATTENED (OUT OF ROUND) IN THIS AREA. DUE TO THE LOCATION AND TYPE OF DAMAGE IT IS LIKELY THIS WAS CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE NOTED WITH HIGH THRESHOLD MEASUREMENTS. THE X-RAY CONFIRMED AN ISSUE WITH THE INSULATION. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. IT WAS INDICATED THAT THIS PATIENT WAS NOT PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617746 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0295| 0695| F140