BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2053070 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03837
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    August 1, 2010
    Report Date
    March 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WILL NOT BE RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER A REVISION PROCEDURE OF THE DEVICE IN 2010 THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THIS LEAD WAS LEFT INSITU. AT THE MOST RECENT FOLLOW UP THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH AND FLUID RETENTION THUS IT WAS ELECTED TO PERFORM A REVISION PROCEDURE. THIS LV LEAD WAS CAPPED AND ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1