BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2171362 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09972
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 9, 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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS LEAD WAS FRACTURED IN TWO PLACES. THE PHYSICIAN WAS UNABLE TO REMOVE THE LEAD; THEREFORE, THE PHYSICIAN REPAIRED THE LEAD. THE IMPEDANCE MEASUREMENT CAME DOWN TO 1700 OHMS. THE LEAD WILL BE MONITORED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD HAD INCREASED THRESHOLD MEASUREMENTS AND IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 4135| 4554| N119| 4136| 1290| 0157