BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2905527 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-15334
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 1, 2009
    Report Date
    October 1, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 RECENTLY RECEIVED INFORMATION THAT THREE YEARS AGO AFTER THE RECENT IMPLANT OF THIS LEFT VENTRICULAR LEAD, A DISLODGEMENT OCCURRED. A REVISION PROCEDURE WAS PERFORMED ONE MONTH AFTER THE IMPLANT TO REPOSITION THE LEAD. THE LEAD CURRENTLY REMAINS IN SERVICE AT THIS TIME THREE YEARS LATER WITH NO ADDITIONAL ALLEGATIONS ON THE LEAD SINCE. NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11197 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4554| 4473| 0158| P107| 4592