BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1946058 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20124
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND WILL BE FURTHER MONITORED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THIS IMPEDANCE MEASUREMENT HAS BEEN INCREASING DURING THE LAST TWO YEARS AFTER A DEVICE REPLACEMENT PROCEDURE HAD BEEN PERFORMED. IN ADDITION, INCREASED THRESHOLDS AND INTERMITTENT LOSS OF CAPTURE WERE REVEALED. THE PATIENT WITH THIS LEAD EXPERIENCED PHRENIC STIMULATION AFTER REPROGRAMMING WAS PERFORMED. AN X-RAY WAS PERFORMED. NO LEAD DISLODGEMENT OR MOVEMENT WAS NOTED. NO FRACTURE WAS NOTED ON THE X-RAY. A FURTHER FOLLOW UP VISIT REVEALED LOSS OF CAPTURE. THE LEAD WAS REPROGRAMMED AND REDUCED THE PHRENIC STIMULATION. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED FURTHER MONITORING THIS LEAD AND RECOMMENDED TO CONTINUE MONITORING UNTIL THE DEVICE REPLACEMENT AT WHICH TIME THIS LEAD CAN BE FURTHER INSPECTED. IT WAS THOUGHT THERE MAY BE A LEAD FRACTURE. 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