BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 2060073 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05920
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    January 8, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    PMA / PMN Number
    P010012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND IS NOT EXPECTED TO BE RETURNED. 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 (LV) LEAD EXHIBITED LOSS OF CAPTURE. THE PATIENT IS PACER DEPENDENT AND WHEN LV ONLY THRESHOLD TESTS WERE PERFORMED, THE PATIENT WAS LIGHTHEADED. IT WAS NOTED THAT THE PATIENT WAS INVOLVED IN AN ACCIDENT WITH AIR BAGS DEPLOYMENT AND HAS NOT FELT WELL SINCE. THE LEAD IMPEDANCE MEASUREMENTS AND SENSING HAVE BEEN STABLE. SEVERAL MONTHS AFTER THE ACCIDENT, THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE DEVICE REPLACEMENT, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED CONTINUED LOSS OF CAPTURE (LOC) AT MAXIMUM OUTPUTS. ADDITIONALLY, HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS WAS OBSERVED. THE LEAD WAS SURGICALLY ABANDONED AND THE PATIENT WAS DOWNGRADED TO A DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT A REVISION PROCEDURE WAS NOT PERFORMED AS THERE WAS NO LEAD FRACTURE. THE DEVICE WAS REPROGRAMMED TO RV ONLY. IT WAS NOTED THAT THE PATIENT WAS SEEN IN THE CLINIC AND INDICATED THEY FEEL GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD NIK BOSTON SCIENTIFIC CORPORATION 4513

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R MISMATCH| 0158| 4513| N118| (B)(4)| H179