BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2163491 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07298
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 26, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASED PACING THRESHOLD MEASUREMENT AND HIGH PACING IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBILITY OF A LEAD FRACTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE LV CONFIGURATION WAS REPROGRAMMED TO RING TO COIL WHICH PRODUCED AN IMPEDANCE MEASUREMENT OF 600 OHMS, A THRESHOLD MEASUREMENT OF 1.0 VOLTS AT 0.4 MILLISECOND, AND NORMAL SENSING MEASUREMENTS. THE PATIENT WOULD BE SEEN IN A FEW MONTHS FOR FURTHER EVALUATION. AN X-RAY WAS NOT PERFORMED.

    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 51 YR 0174| 4555| 4592| 4469| H220