BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1950483 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22937
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 12, 2010
    Report Date
    November 12, 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

    MOST RECENT INFORMATION INDICATES THAT THIS LEAD WAS EXPLANTED AND HAS NOT YET BEEN RETURNED TO THE BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY. INVESTIGATION IS CONSIDERED CLOSED AT THIS TIME. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD HAD BECOME DISLODGED WITHIN ONE DAY OF IMPLANT. INTERMITTENT LOSS OF CAPTURE AND ELEVATED PACE THRESHOLDS WERE EVIDENT. INITIALLY THE PLAN WAS TO RETAIN THE LEAD, UNTIL IT WAS DETERMINED THAT THE LEAD HAD BECOME DISLODGED. THERE WERE NO ADVERSE PATIENT EFFECTS, BEYOND THE SURGICAL INTERVENTION THAT OCCURRED TO ADDRESS THIS ISSUE.

    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