BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210126 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06599
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THIS LEAD AND DEVICE REMAIN IMPLANTED AND IN SERVICE. 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 DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED AN IMPEDANCE MEASUREMENT DECREASE OF GREATER THAN 500 OHMS. THIS APPEARED A ONE TIME INCIDENT THAT OCCURRED APPROXIMATELY SEVEN MONTHS AGO. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THIS INFORMATION. NON-SUSTAINED VENTRICULAR TACHYCARDIA EVENTS WERE STORED IN THE ARRYTHMIA LOGBOOK. NO NOISE WAS OBSERVED. TS THOUGHT THE IMPEDANCE MEASUREMENT MAY HAVE BEEN DUE TO A CHANGE IN THE PATIENT CONDITION OR MEDICATION AND RECOMMENDED FURTHER LEAD INTEGRITY VERIFICATION DURING A FUTURE VISIT. IT WAS THOUGHT THIS LEAD AND ASSOCIATED DEVICE WERE FUNCTIONING APPROPRIATELY AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309634 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1