BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2040808 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00751
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P050046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED. THE SYSTEM WAS EXPLANTED DUE TO DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. AN INVASIVE SURGICAL PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED. A NEW LV LEAD WAS NOT IMPLANTED DUE TO TORTUOUS PATIENT ANATOMY. DURING THE PROCEDURE, THE IMPLANTING PHYSICIAN CUT THROUGH THE COMPETITOR RIGHT ATRIAL (RA) LEAD. THE RA LEAD WAS CAPPED AND REPLACED. THE COMPETITOR RIGHT VENTRICULAR (RV) LEAD WAS INSERTED INTO THE LV PORT OF THE DEVICE AND A NEW RV LEAD WAS IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization (B)(4)| (B)(4)| 3830| 4548| 4555