BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910867 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15848
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    June 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT OUT OF RANGE MEASUREMENTS CONTINUED TO BE OBSERVED. THE PATIENT WAS BROUGHT INTO THE CLINIC AND THE LEAD CONFIGURATION VECTORS WERE CHANGED IN AN ATTEMPT TO RESOLVE OUT OF RANGE MEASUREMENTS. PATIENT NOTED BEING COMPLETELY DEPENDENT. PACING IMPEDANCES AND THRESHOLDS ARE NORMAL AND PATIENT IS BEING PACED AT 30 BEATS PER MINUTE (BPM). THE PATIENT HAS THE OLD PACEMAKER STILL IMPLANTED ON THE RIGHT SIDE CURRENTLY NOT IN SERVICE. THE LEFT VENTRICULAR (LV) LEAD IS FUNCTIONING FINE AND HAS GOOD IMPEDANCE, SO THIS IS NOTED AS A BACKUP IF RV LOSES CAPTURE. PHYSICIAN DECIDED TO TURN OFF TACHY THERAPY ON THE DEVICE, SO CURRENTLY USING DEVICE AS A BIV PACER. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WHERE THE ISSUE MAY BE WITH THE SLI IF IT IS DISTAL TO THE YOKE THEN THE RV COIL IS COMMON FOR PACING AND SHOCKING. IF IT IS PROXIMAL TO THE YOKE, BETWEEN THE YOKE AND THE DEVICE, THEN THE SHOCKING PORTION AND THE PACING PORTION ARE SEPARATE, SO A FRACTURE IN THE RV SHOCKING LEG WOULD NOT IMPACT PACING. TS STATED THEY CANNOT GUARANTEE THAT PACING WILL BE FINE, BECAUSE DON'T KNOW MECHANISM OF FAILURE, BUT SINCE PACE IMPEDANCE AND THRESHOLD HAVEN'T CHANGED AT THE SAME TIME THAT THE SLI WENT >200 OHMS, THEN IT IS POSSIBLE THAT PACING WILL BE UNCHANGED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THROUGH A REMOTE MONITORING SYSTEM THAT DETECTED AN OUT OF RANGE HIGH SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS NO INFORMATION IMMEDIATELY AVAILABLE. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT OUT OF RANGE IMPEDNACE MEASUREMENTS CONTINUED TO BE OBSERVED. THE PATIENT WAS GOING TO BE BROUGHT IN FOR EVALUATION. A REQUEST FOR OUTCOME HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16821 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 1298| 4479| 4554| N119| 4456| 0185| 4470