BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 2163476 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07466
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN SURGICALLY ABANDONED THIS LEAD. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. AN ACUTE RV LEAD WAS SUCCESSFULLY IMPLANTED IN LIEU. THE ASSOCIATED ICD WAS TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS PURPOSES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID BECOME DAMAGED BEYOND REPAIR AS A RESULT OF USER ERROR. DURING THE NORMAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT, THE IMPLANTING PHYSICIAN NEGLECTED TO LOOSEN THE DISTAL SETSCREW ON THE DEVICE BEING CHANGED OUT. THE PHYSICIAN THOUGHT THIS RV LEAD WAS STUCK, PULLED ON IT, AND AS A RESULT, THE CONNECTOR PIN SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 0185| 1860| 1782| 6936| 0125| E102| 6933