BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913176 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16751
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 9, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. NOISE WAS ABLE TO BE PRODUCED ON THE SHOCK CHANNEL. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATED THAT THE DEVICE WAS REPROGRAMMED TO A NON-TRIAD CONFIGURATION AS IMPEDANCES WERE THEN WITHIN RANGE. OF NOTE, THE PATIENT HAD BEEN SEEN AT A FREE CLINIC WHERE THERE WAS NO ACCESS TO A ELECTROPHYSIOLOGIST. THE PATIENT WILL BE SEEN FOR FOLLOW UP IN 3 MONTHS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19716 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR 0158| E051| 1860