BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2161224 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-06766
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN 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.

    Additional Manufacturer Narrative · 1

    THE ONLY ADDITIONAL INFORMATION PROVIDED WAS THAT THIS OCCURRED DURING AN ABLATION PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED LOW PACING AND LOW SHOCK IMPEDANCES ON THIS RIGHT VENTRICULAR LEAD. IN ADDITION, THE PACING IMPEDANCES ON THE RIGHT ATRIAL LEAD HAD DECLINED FROM THE MID 500 OHMS RANGE TO THE MID 300 OHMS RANGE. LASTLY, THERE WAS NOISE PRESENT ON ALL THREE CHANNELS THAT WAS OVERSENSED RESULTING IN PACING INHIBITION. HOWEVER, THE PATIENT DID HAVE AN UNDERLYING RHYTHM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WAS TO BE FURTHER EVALUATED FOR THESE ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR T125| 0158| E110| 4473