BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2151123 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07863
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS FURTHER INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. IN ADDITION THIS LEAD WAS ALSO DISPLAYING HIGH PACING THRESHOLDS AND LOSS OF CAPTURE AT HIGH OUTPUTS. LEAD DISLODGEMENT WAS SUSPECTED. THIS LEAD WAS DEACTIVATED TO PREVENT BATTERY DEPLETION. A REVISION PROCEDURE IS INTENDED IN THE FUTURE. ADDITIONAL INFORMATION WAS RECEIVED THAT A LEAD REPOSITIONING PROCEDURE WAS PERFORMED. THE DECISION WAS MADE TO ADD A STENT TO HELP KEEP THE LV LEAD IN PLACE. ONCE THE STENT WAS IN PLACE POST OPERATIVE TESTING WAS DONE WHICH REVEALED NORMAL AND WITHIN RANGE MEASUREMENTS. THE NEXT DAY IT WAS NOTED THE PACING THRESHOLDS SLIGHTLY INCREASED AND PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. DUE TO THESE ISSUES, THE PHYSICIAN ELECTED TO TURN LV THERAPY OFF FOR THE TIME BEING. 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 4554

    Patients

    Seq Age Sex Outcome Treatment
    1