BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041189 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01262
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS RIGHT VENTRICULAR LEAD AND DEVICE REMAIN IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A FURTHER OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT HAD BEEN RECORDED, HOWEVER THERE HAD BEEN NO ALERT, HOWEVER TS REVIEWED THE DATA AND DETERMINED THE OUT OF RANGE MEASUREMENT HAD OCCURRED PRIOR TO THE RESET OF PREVIOUS OUT OF RANGE MEASUREMENT. FURTHER REVIEW OF THE DATA DETERMINED THAT THE SHOCK IMPEDANCE MEASUREMENT REVEALED NOISE DURING DEVICE PACING. FURTHER LEAD INTEGRITY INVESTIGATION WAS RECOMMENDED.

    Description of Event or Problem · 1

    A FOLLOW UP VISIT WAS PERFORMED. NO NOISE EPISODES WERE OBSERVED DURING POCKET MANIPULATION, ISOMETRIC AND ARM MOVEMENTS. SHOCK IMPEDANCE MEASUREMENTS WERE NORMAL WITH THE LEFT ARM IN NORMAL POSITION AND HIGH WHEN THE LEFT ARM WAS POSITIONED ABOVE THE HEAD. SEVERAL MANEUVERS REVEALED SIMILAR RESULTS. IT WAS THOUGHT THERE WAS AN ISSUE AT THE DEVICE POCKET SITE CAUSING AN INTERMITTENT CONTACT WITH THE DEVICE. ALTHOUGH LEAD INTEGRITY TESTING WAS RECOMMENDED, DUE TO THE PATIENT¿S CONDITION, A DECISION WAS MADE TO FURTHER MONITOR THIS SYSTEM WITH REMOTE MONITORING AND FREQUENT FOLLOW UP VISITS. ALL RV LEAD MEASUREMENTS WERE NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, A SAVE TO DISK WAS PROVIDED TO TECHNICAL SERVICES FOR THEIR REVIEW. SEVERAL HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS HAVE BEEN RECORDED AND THE RIGHT VENTRICULAR LEAD IMPEDANCE MEASUREMENTS HAVE DECREASED DURING THE PAST FEW MONTHS. THE ARRHYTHMIA LOGBOOK REVEALED NUMEROUS VENTRICULAR EPISODES HAD OCCURRED AND THERE IS NOISE ON THE RIGHT VENTRICULAR AND SHOCK CHANNELS. IN ADDITION ANTITACHYCARDIA PACING WAS DELIVERED. THE NOISE COULD NOT BE REPRODUCED BY THE PHYSICIAN. THE DEVICE WAS REPROGRAMMED. FURTHER SYSTEM INTEGRITY INCLUDING AN HIGH RESOLUTION X-RAY OF THE HEADER WAS RECOMMENDED TO VERIFY WHETHER THERE MAY BE A SUB OPTIMAL CONNECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A DECISION HAS BEEN MADE TO PERFORM A LEAD REVISION IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    - -

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142654 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 0181| 0171| 4480| 4554| P107