BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3904545 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10911
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. 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 LEAD WAS SUCCESSFULLY IMPLANTED. LIMITED OPTIONS WERE AVAILABLE FOR PLACEMENT DUE TO VENOUS ANATOMY. WHEN THE CATHETER WAS CUT AWAY, THE LEAD MOVED BACK SLIGHTLY. THRESHOLDS MEASUREMENTS WERE ACCEPTABLE. ONE HOUR POST PROCEDURE, THE PATIENT WITH THIS LEAD EXPERIENCED DIAPHRAGMATIC STIMULATION. THE DEVICE WAS REPROGRAMMED RESOLVING THE ISSUE. IT WAS THOUGHT THE LEAD MAY MOVE, BUT A DECISION WAS MADE TO REVIEW AT THE POST OP FOLLOW UP. THE FOLLOWING MORNING, THRESHOLD MEASUREMENTS HAD FURTHER INCREASED, BUT WAS STILL CAPTURING WITH NO STIMULATION REPORTED. A DECISION WAS MADE TO FURTHER FOLLOW UP AND A DECISION WILL BE MADE REGARDING REVISION OR LEAVE THE LEAD IMPLANTED DUE TO THE LACK OF VENOUS ACCESS. FURTHER FOLLOW UP WAS PERFORMED. THE PHYSICIAN FELT THIS LEAD MAY HAVE MICRODISLODGED. AS THE THRESHOLDS SETTLED TO AROUND 2.5V, A DECISION WAS MADE TO LEAVE THIS LEAD IMPLANTED. NO REVISION PROCEDURE WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383470 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 N162| 4543| 4480| 0292