BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 3761243 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08151
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH THIS LEFT VENTRICULAR (LV) LEAD SYSTEM EXHIBITED INTERMITTENT HIGH PACING IMPEDANCE MEASUREMENT OF MORE THAN 2,000 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED TO EVALUATE LV LEAD IN DIFFERENT CONFIGURATIONS AND DISCUSSED TO MONITOR LV LEAD PACING THRESHOLD. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF OUT OF RANGE MEASUREMENT WAS NOT DETERMINED. THE SYSTEM WAS TESTED IN ALL CONFIGURATIONS BUT THE RESULT WAS NOT PROVIDED BY THE FIELD REPRESENTATIVE. IN ADDITION, A LV LEAD EXTRACTION WAS PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240675 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR H210| 5076| 4555| 6945| N161| 1388TC| A155| 1851