BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2911919 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16797
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE ALLEGATIONS OF DISLODGMENT AND HIGH PACING THRESHOLD MEASUREMENTS INVOLVING THIS LEAD COULD NOT BE CONFIRMED BY TESTING. THERE WAS NOTHING VISUALLY WRONG WITH THE LEAD THAT WOULD HAVE CAUSE DISLODGMENT. THE ALLEGATION OF A STYLET NOT BEING ABLE TO BE PASSED THROUGH THE LUMEN WAS CONFIRMED BY TESTING. THE LEAD WAS AN OPEN LUMEN LEAD AND BLOOD SEEPED UP INTO THE LUMEN WHILE BEING IMPLANTED. THE BLOOD DRIED CAUSING THE GUIDEWIRE TO NOT BE FULLY INSERTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED AND HAD HIGH PACING THRESHOLDS MEASUREMENTS AT 6 VOLTS AT 2 MILLISECONDS. UPON TRYING TO REPOSITION THE LEAD, A STYLET COULD NOT BE PASSED THROUGH THE LUMEN, SO THE LEAD WAS REMOVED WITHOUT INCIDENT FROM SERVICE AND WAS EXPLANTED. A REPLACEMENT LV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18157 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R 4087| (B)(4)| 4555| 0185| 4088| N119| 4543