BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2162553 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07366
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AND INCREASED THRESHOLD MEASUREMENTS. A REVISION PROCEDURE WAS PERFORMED; DURING WHICH AN LV LEAD DISLODGEMENT WAS SEEN ON THE FLUOROSCOPIC IMAGE. THE LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IMPLANTED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE LEAD REVISION PROCEDURE WERE REPORTED.

    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 83 YR Hospitalization| L| R 5076| N119| 7288| 4592| 6944