BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3760894 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08764
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 26, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A COMPLETE LEAD WAS RETURNED. ANALYSIS REVEALS ALL COILS FRACTURED APPROXIMATELY 41 CM FROM THE TERMINAL PIN, POSSIBLY A SUTURE SLEEVE TIE-DOWN LOCATION.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AND PACING THERAPY WAS NOT DELIVERED WHEN IT WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEAD SUSTAINED DAMAGE TO THE INSULATION, LEAD BODY AND CONDUCTOR COILS. THE FRACTURE TO THE CONDUCTORS WAS CONFIRMED VIA CHEST X-RAY. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239828 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 0295| 4470| N140| 4543