BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 2050712 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03773
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW SHOCK IMPEDANCE MEASUREMENT LESS THAN 20 OHMS WHILE TRYING TO DELIVER THERAPY. THERE WAS NOISE ALSO PRESENT. THE PACING IMPEDANCE MEASUREMENT REMAINS WITHIN NORMAL LIMITS. THE DEVICE THERAPY WAS TURNED OFF AND THE PATIENT WAS SCHEDULED FOR AN EVALUATION TO DETERMINE FURTHER ACTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK C IMPLANTABLE LEAD NVY HISTORICAL PUERTO RICO 0074

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention (B)(4)| 1786| MISMATCH| 0074| 1857