BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3961707 · Received July 28, 2014

    Report

    Report Number
    2124215-2014-14541
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD REPORTED TO HAVE BEEN HEARING DEVICE TONES. THE PATIENT WAS SEEN IN CLINIC FOR FOLLOW UP WHERE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS WERE DISCOVERED. AN X-RAY WAS PERFORMED WHERE A FRACTURE WAS VISUALIZED NEAR THE AREA OF THE PATIENT'S CLAVICLE. THIS WAS THEN CONFIRMED VIA FLUOROSCOPY. THE PATIENT WAS SUBSEQUENTLY SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439195 EASYTRAK 3 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4525

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R 4470| 0185| N118| H179| 4525