BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2 IS-1

    MDR report key: 10617875 · Received October 1, 2020

    Report

    Report Number
    2124215-2020-16794
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    July 15, 2020
    Report Date
    October 8, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526410901
    PMA / PMN Number
    P010012/S024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE 3191 CAPTURES THE REPORTABLE EVENT OF SURGERY. CORRECTION TO H6: ADDED DEVICE CODE "1581: FAILED TO READ INPUT SIGNAL".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD ISSUES, AS THE PATIENT'S NATIVE QRS WAVES WAS NARROWER THAN THE PACED QRS WAVES. THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO ABANDON THE LEAD. NO NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD ISSUES, AS THE PATIENT'S NATIVE QRS WAVES WAS NARROWER THAN THE PACED QRS WAVES. THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO ABANDON THE LEAD. NO NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076356 EASYTRAK 2 IS-1 IMPLANTABLE LEAD NIK BOSTON SCIENTIFIC CORPORATION 4542 133036 00802526410901

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R