BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2180960 · Received July 27, 2011

    Report

    Report Number
    2124215-2011-12704
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    June 23, 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

    AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS LEFT VENTRICULAR (LV) PACING LEAD EXPERIENCED DIAPHRAGMATIC STIMULATION. THE LEAD WAS PROGRAMMED TO LV RING TO RIGHT VENTRICULAR (RV) COIL WHICH MITIGATE SOME OF THE DIAPHRAGMATIC STIMULATION, HOWEVER HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE OBSERVED. THE LEAD WAS PROGRAMMED TO LV TIP TO RV COIL WHICH RESULTED IN ACCEPTABLE IMPEDANCE MEASUREMENTS. THE LV OUTPUTS WERE THEN LOWERED TO MITIGATE THE DIAPHRAGMATIC STIMULATION. THERE WAS A CONCERN THE LEAD WAS FRACTURED; HOWEVER, THE FIELD REPRESENTATIVE INDICATED THE PATIENT DID WELL AFTER REPROGRAMMING SO NO FURTHER INTERVENTION WILL BE PERFORMED. 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 84 YR 4555| 1688T| 5092| E2DR01| N119| MISMATCH