BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2914314 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00935
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 29, 2012
    Report Date
    January 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE COMPLETE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. BLOOD/BODY FLUID WAS NOTED IN THE LUMEN. A FINISHING WIRE WAS PARTIALLY INSERTED AND STUCK IN THE LEAD LUMEN. THE LEAD TIP WAS INTACT AND UNDAMAGED. THE LEAD WAS DETERMINED TO HAVE BEEN ELECTRICALLY CONTINUOUS. THE CLINICAL OBSERVATIONS WERE NOT ABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE LEAD IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD DISPLAYED LOSS OF CAPTURE. THE LEAD WAS FOUND TO HAVE DISLODGED. A REVISION PROCEDURE WAS PERFORMED WHERE THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19681 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R N119| 0185| 4470| 4592