BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3061774 · Received April 16, 2013

    Report

    Report Number
    2124215-2013-06285
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    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. A SAVE TO DISC WAS SENT IN TO BOSTON SCIENTIFIC TECHNICAL SERVICES. DAILY SHOCK IMPEDANCE MEASUREMENTS WERE REVIEWED AND MOST DAILY MEASUREMENTS WERE BETWEEN 70-80 OHMS. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATED THAT NO TROUBLE-SHOOTING WAS PERFORMED AND THAT THE PATIENT WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162581 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR T175| 4470| E163| 0185