BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1952863 · Received January 7, 2011

    Report

    Report Number
    2124215-2011-00338
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    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 THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, THIS LEAD EXHIBITED ELEVATED THRESHOLD MEASUREMENTS; DISLODGEMENT WAS CONFIRMED VIA X-RAY. THE PATIENT WAS DISCHARGED THAT DAY WITH AN APPOINTMENT TO FOLLOW-UP IN THE PHYSICIAN'S OFFICE IN THREE WEEKS. PROGRAMMING OUTPUTS WERE INCREASED TO PROVIDE APPROPRIATE LV CAPTURE. NO ADVERS AFFECTS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1