BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3213536 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-07011
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 8, 2013
    Report Date
    March 3, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    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

    ADDITIONAL ANALYSIS INDICATES THAT THE RETURNED SEGMENT OF THIS LEAD WAS EVALUATED AND IT SHOWED THAT THE TERMINAL SEGMENT OF THIS LEAD WAS SEVERED FROM THE TERMINAL PIN. DRAG MARKS WERE ALSO NOTED ON THE TERMINAL RING. NO DETAILED ANALYSIS WAS CONDUCTED. THE RETURNED SEGMENT OF THIS LEAD PASSED ELECTRICAL TESTING.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, NO FURTHER TESTING WAS DONE HOWEVER, IT WAS CONCLUDED THAT IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. CHEST X-RAY SHOWED THAT THE LEAD WAS SLIGHTLY HANGING. FIELD REPRESENTATIVE REPORTED OF STILL GETTING SOME LV SENSING EVENTS COMING THROUGH THE TIP. CAN CONFIGURATION WAS PERFORMED AND LV SENSING HAS BEEN TURNED OFF. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE THAT NO LEAD REVISION WAS PERFORMED AND THE PHYSICIAN CHOSE TO KEEP AS IS AND MONITOR THE PATIENT. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO HIGH PACING THRESHOLD. THE DEVICE WAS ALSO CHANGED FOR THERAPY UPGRADE/DOWNGRADE PER TRAC FORM. THE LV LEAD WAS FOR RETURN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313203 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4135| N160| 4543| S403| 4136