BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1874113 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18989
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS ELECTRICALLY ABANDONED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE DEVICE WAS REPROGRAMMED TO PROVIDE ONLY RIGHT VENTRICULAR THERAPY AND THE AV DELAY WAS EXTENDED TO 240MS. 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 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 4470| N119| 4554| 0185