BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3053327 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05580
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    August 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS FOUND TO HAVE TWIDDLERS SYNDROME, AND TWIDDLED THE RV AND LV LEAD. THE RV LEAD WAS SUCCESSFULLY ABANDONED AND SUCCESSFULLY REPLACED, AND THE LV LEAD WAS PARTIALLY ABANDONED AND REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD A CHEST X-RAY TAKEN AND IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AND WAS DISLODGED. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD ALSO SHOWED INCREASED THRESHOLDS AND WAS THOUGHT TO HAVE MICRO DISLODGED AS WELL. THE DEVICE HAD ALSO MIGRATED A BIT SINCE IMPLANT. THE PHYSICIAN NOTED THAT THE RECENT ECHOCARDIOGRAM SHOWED A DRAMATIC INCREASE IN THE PATIENT'S EJECTION FRACTION SO THE DECISION WAS MADE TO NOT CHANGE ANYTHING AT ALL IN THIS PATIENT AND LEAVE AS IS. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154839 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 0181| 4054| 4543| N141| H210