BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2172973 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10165
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 9, 2010
    Report Date
    June 10, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPERIENCING DIAPHRAGM STIMULATION. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPOSITIONED. THE FOLLOWING DAY, ELEVATED THRESHOLDS MEASUREMENTS WERE OBSERVED AND THE LEAD APPEARED TO HAVE MIGRATED THROUGH A SMALL BRANCH AND OUTSIDE THE VESSEL WALL. AN ADDITIONAL PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4592| 0185| 4473| H227