BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 2163475 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07406
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD EXHIBITED NOISE AND AS A RESULT DELIVERED AN INAPPROPRIATE SHOCK TO THE PATIENT. AS A RESULT THE PHYSICIAN ELECTED TO SURGICALLY GO IN AND TURN OFF THE DEVICE AND ABANDONED THE LEAD. A NEW DEVICE SYSTEM WAS IMPLANTED ON THE PATIENTS OTHER SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK C IMPLANTABLE LEAD NVY HISTORICAL CPI ST. PAUL 0064

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 0184| 1600| 1857| E102| 0064| 1725