BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 4145201 · Received October 6, 2014

    Report

    Report Number
    2124215-2014-14707
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    July 15, 2014
    Report Date
    August 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. REQUEST HAD BEEN MADE FOR THIS PRODUCT TO BE RETURNED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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 HAD DISLODGED. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD BUT THE LEAD BACKED OUT OF THE VESSEL WHILE SUTURING. THE PHYSICIAN IMPLANTED A DIFFERENT LEAD IN A DIFFERENT VESSEL AND WAS SUCCESSFUL. ADDITIONAL INFORMATION INDICATED THAT THE LEAD EXHIBITED HIGH PACING THRESHOLD AND DISLODGEMENT WAS CONFIRMED VIA X-RAY APPROXIMATELY A MONTH FOLLOWING THE INITIAL IMPLANT. THE LV LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. THIS LEAD WILL BE RETURNED BACK TO LABORATORY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623142 EASYTRAK 3 IMPLANTABLE LEAD LWP CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R T167| 1853| 7274| 6947| 5076| 4543| 4549| N161