BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2151696 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-05978
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 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

    THE LEAD REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD BEEN FEELING TIRED. AT A ROUTINE FOLLOW UP VISIT, THIS LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING NO CAPTURE, DECREASED SENSING MEASUREMENTS AND THE PACING PERCENTAGE HAD DROPPED FROM 95% TO 59%. AN X-RAY REVEALED THE LEAD HAD DISLODGED. SOME DEVICE REPROGRAMMING WAS PERFORMED TO ADDRESS THE REPORTED CLINICAL OBSERVATIONS. THE CALLER WILL DISCUSS THE ISSUES WITH THIS PATIENT'S PHYSICIAN. NO ADVERSE PATIENT EFFECTS 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 71 YR H175| 4592| 0180| 0157| 4469| N119| 4518