BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2171290 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09843
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    May 4, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF PRODUCT IS INTENDED. AS NO FURTHER INFORMATION REGARDING THIS EVENT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR LEAD DISPLAYED LOSS OF CAPTURE. AN X-RAY REVEALED THIS LEAD WAS DISLODGED. THIS LEAD WAS REMOVED AND AN TWO ATTEMPTS TO REPLACE THE LEAD WERE UNSUCCESSFUL. AN ECHO WILL BE PERFORMED IN THE FUTURE TO DETERMINE WHETHER ANOTHER LEFT VENTRICULAR LEAD IS NEEDED. 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 Required Intervention