BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3911638 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-10775
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 18, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS GETTING HOT AND SO THE PATIENT FELT THE SKIN WAS BURNING. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION WAS UNSUCCESSFUL. THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391189 EASYTRAK 3 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4525

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R H215| 4525| N164| H225| 4470| 0185