BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2171571 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10928
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. ELECTRICAL TESTING CONFIRMED THE LEAD TO BE ELECTRICALLY CONTINUOUS. THE STYLET INSERTION TEST FAILED AS A RESULT OF DRIED BODY FLUID IN THE LUMEN (TIP AREA). NO FURTHER TESTING WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS FOUND TO EXHIBIT LOSS OF CAPTURE (LOC) DURING A ROUTINE IN CLINIC FOLLOW UP APPOINTMENT. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND UPON FLUOROSCOPIC EXAMINATION, THE LV LEAD WAS FOUND TO HAVE DISLODGED. THE LV LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    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 79 YR Hospitalization| R 0185| 4470| 4592| N119| 4555