BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2163478 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07908
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    January 11, 2011
    Report Date
    December 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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

    ADDITIONAL INFORMATION WAS PROVIDED THAT THIS LEAD WAS REMOVED FROM SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD NOTED THAT THEIR DEVICE HAD MIGRATED UNDER HER ARMPIT AND WAS SUBSEQUENTLY REPOSITIONED. THE PATIENT THEN NOTED THAT THE DEVICE HAD ERODED THROUGH THEIR INCISION AND WAS REPOSITIONED AGAIN. THEN THE PATIENT NOTED HAVING SWELLING AND DRAINAGE FROM THE DEVICE INCISION AND FEELING SMALL "SHOCKS" FROM DEVICE AREA. TECHNICAL SERVICES (TS) DISCUSSED THAT SOME PEOPLE HAVE LOOSER SKIN OR MUSCLE TONE SO IT CAN BE MORE DIFFICULT FOR THE DEVICE TO STAY IN PLACE, AND RECOMMENDED DISCUSSING FURTHER WITH HER PHYSICIAN. AT THIS TIME, ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 4524| H229| 0181| 4517| 4086