BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771152 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12217
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 4, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS EXPLANTED AND REPLACED AFTER EXHIBITING PACING INHIBITION DUE TO NOISE. THE PATIENT IS PACING DEPENDENT. LEAD IMPEDANCE AND PACING THRESHOLD MEASUREMENTS WERE NORMAL. THERE WERE NO ADVERSE PATIENT EFFECTS. THE LEAD WAS SUCCESSFULLY EXTRACTED, BUT DAMAGED DURING THE PROCEDURE AND DISCARDED AT THE EXPLANTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention N119| 4136| 4137| 0158