BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1851863 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14571
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RIGHT ATRIAL, AND CORONARY SINUS LEADS WERE EXPLANTED DUE TO A PATIENT INFECTION. AN ATTEMPT WAS MADE TO EXPLANT THE DEFIBRILLATION LEAD HOWEVER, THIS LEAD COULD NOT BE EXPLANTED. THE DEVICE ALSO HAD ERODED THROUGH THE SKIN. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. A REQUEST WAS MADE FOR PRODUCT RETURN.

    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 59 YR Required Intervention 4555| 4470| 4592| N119| 0185