BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3050060 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03535
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 27, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE SAVE TO DISK BY ENGINEERING AND TECHNICAL SERVICES NOTED THAT THE DEVICE HAD NO RESETS AND ONE FAULT FOR LOW R WAVE MEASUREMENTS. THE BATTERY STATUS WAS AT BOL, THE DEVICE APPEARED TO BE FUNCTIONING PROPERLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM TECHNICAL SERVICES NOTED THAT A RIGHT VENTRICULAR LEAD ISSUE WAS SUSPECTED. TECHNICAL SERVICES DISCUSSED THAT THE PACING INHIBITION NOTED IS MOST LIKELY DUE TO A LEAD INTERMITTENT MECHANICAL ISSUE OR A LEAD/TISSUE INTERFACE PROBLEM OR AN INTERMITTENT CAPTURE WITH THE PREVIOUSLY PROGRAMMED LOWER RIGHT VENTRICULAR OUTPUTS, ALTHOUGH NONE OF THE SCENARIOS CAN BE CONFIRMED AT THIS TIME. AT THIS TIME THE SYSTEM REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SHOWED 10 SECONDS OF ASYSTOLE DUE TO LOSS OF CAPTURE WHICH RESULTED IN SYNCOPE. THE DEVICE RECORDED SEVERAL RVP WHICH WERE NOT FOLLOWED BY RV CAPTURE CAUSING THE PATIENT SYNCOPE. NO NOISE WAS RECORDED AND THE RIGHT VENTRICULAR PACING IMPEDANCES AND PACING THRESHOLDS APPEAR STABLE. TECHNICAL SERVICES WAS CONTACTED, AND DISCUSSED PERFORMING DEEP ISOMETRIC AND POCKET MANIPULATION. A SAVE TO DISK AND MEMORY DUMP WAS REQUESTED FOR FURTHER EVALUATION. AT THIS TIME THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149556 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening