BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK C

    MDR report key: 2924878 · Received January 22, 2013

    Report

    Report Number
    2124215-2013-01497
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS IN RA COIL TO CAN CONFIGURATION. BOSTON SCIENTIFIC (BSC) TECHNICAL SERVICES DISCUSSED TROUBLE-SHOOTING OPTIONS WITH THE LOCAL BSC FIELD REPRESENTATIVE (FR). THE FR INDICATED THAT DEFIBRILLATION THRESHOLD TESTING WOULD BE DONE AT SOME POINT IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AVAILABLE INFORMATION INDICATES THAT THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30646 ENDOTAK C IMPLANTABLE LEAD NVY HISTORICAL CPI ST. PAUL 0064

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 6931| E141| 0064| 1645| 1857| 6162| 1555