BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3053585 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05400
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE LEAD HAS NOT BEEN RECEIVED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    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

    SUBSEQUENT INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEEN FOR A LEAD REVISION PROCEDURE. THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD IS TO BE RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISPLAYED AN INABILITY TO CAPTURE AT MAXIMUM OUTPUT. R-WAVES AND IMPEDANCE HAD ALSO DROPPED. A CHEST X-RAY WAS PERFORMED WHICH CONFIRMED A DISLODGMENT OF THE LEAD. THE DEVICE WAS REPROGRAMMED TO VVI 40 AND A LEAD REVISION PROCEDURE WAS SCHEDULED FOR A LATER DATE. THERE WERE NO ADVERSE PATIENT EFFECTS. AS OF TODAY, THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156493 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R T135| 0157| 0185| 4542| N141| 1860| MISMATCH