BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3223531 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10198
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 3, 2013
    Report Date
    September 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE ALLEGATION OF THE LEFT VENTRICULAR (LV) LEAD DISLODGEMENT COULD NOT BE CONFIRMED BY ANALYSIS. VISUAL INSPECTION HAVE ALSO REVEALED THAT THE OUTER CONDUCTOR COILS WERE SLIGHTLY DEFORMED. THE LEAD TIP HAS NO VISIBLE SIGNS OF DAMAGE OR DEFECT WHICH COULD LEAD TO DISLODGEMENT. ANALYSIS HAVE DETERMINED THAT THE LEAD WAS OUT OF SPECIFICATIONS NON-CLINICALLY, DUE TO IMPROPER USER HANDLING IN THE FIELD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED AND WAS REPLACED BY A COMPETITOR LEAD. THE LEAD WAS EXPLANTED AND WILL NOT BE RETURNED. NO ADDITIONAL 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
    323317 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R H217| MISMATCH| 4549| N161| 4469| 0184