BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2040986 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00728
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LV LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A LOSS OF CAPTURE (LOC), AND PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS IN BIPOLAR CONFIGURATION. THIS PATIENT WAS PREVIOUSLY HOSPITALIZED FOR CHRONIC HEART FAILURE (CHF). THE DECISION WAS MADE TO REPROGRAM THE PACING CONFIGURATION TO LV TIP TO RIGHT VENTRICULAR (RV) RING, WHICH RESULTED IN APPROPRIATE IMPEDANCE AND THRESHOLD MEASUREMENTS. IT WAS SUSPECTED THERE MIGHT BE INSULATION DAMAGE OR LEAD CONDUCTOR FRACTURE. THIS PATIENT IS PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS REPORTED, AND PATIENT WILL BE FOLLOWED-UP WITHIN THE NEAR FUTURE.

    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