BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 3211068 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08091
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED, BUT ABANDONED ELECTRICALLY. 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 CHRONIC LV LEAD WAS TESTED DURING THE DEVICE REPLACEMENT PROCEDURE, WITH GOOD LEAD MEASUREMENTS OBSERVED. AFTER THE POCKET WAS CLOSED, THE LV LEAD WAS TESTED AGAIN AND IT WAS NOTED THAT THE PACING THRESHOLD MEASUREMENTS HAD INCREASED TO 7.5V. AN X-RAY WAS PERFORMED, WHICH REVEALED THE LV LEAD TIP HAD MIGRATED APPROXIMATELY ONE CENTIMETER FROM THE ORIGINAL POSITION. THE DEVICE WAS REPROGRAMMED TO RV ONLY PACING AND THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309737 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1