BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1894504 · Received November 9, 2010

    Report

    Report Number
    2124215-2010-21841
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    January 15, 2010
    Report Date
    July 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALED THAT THE COMPLETE LEAD WAS RETURNED. THERE WAS BLOOD/BODY FLUID NOTED IN THE LUMEN. THERE WAS ONE SETSCREW MARK NOTED ON THE TERMINAL PIN AND NO DISCERNABLE SETSCREW MARK ON THE RING. THE CONDUCTOR COILS WERE DEFORMED AT 365 MILLIMETERS FROM THE TERMINAL PIN. THE LEAD BODY INSULATION WAS TWISTED. THE LEAD WAS FOUND TO BE ELECTRICALLY CONTINUOUS AND THERAPY WAS CONFIRMED TO BE AVAILABLE. IT WAS CONCLUDED THAT THE LEAD BODY INSULATION WAS TWISTED MOST LIKELY DUE TO TWIDDLER'S.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED TWIDDLER'S, SUBSEQUENTLY THE LEAD HAD DISLODGED. THE LEAD WAS UNABLE TO BE RE-USED THEREFORE, A NEW LEAD WAS PLACED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 45 YR Required Intervention 4135| 0184| N119| 4554