BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2911777 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16353
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD AND ADAPTER COMPLAINED OF MUSCLE STIMULATION. THE PHYSICIAN BELIEVED THAT THE LEAD HAD MIGRATED FROM ITS ORIGINAL POSITION. THE LEAD ALSO DISPLAYED PACING IMPEDANCES OF LESS THAN 200 OHMS. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS REPOSITIONED AND THEN ATTACHED TO A NEW ADAPTER. THE LEAD WAS THEN TESTED WITH THE NEW ADAPTER WITH NORMALIZATION OF IMPEDANCE MEASUREMENTS AND NO MUSCLE STIMULATION. THE LEAD REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16919 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 1823| 4513| 4549| 4055| 0125| 0185| 1763| 4402| H175| N118