BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3921910 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-10825
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THIS LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE DISLODGED, AND EXHIBITED LOSS OF CAPTURE (LOC) DUE TO HIGH PACING THRESHOLD. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401214 EASYTRAK 3 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R H175| MISMATCH| 4555| H219| 4470| 4524| N141| 0158