BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2062460 · Received April 19, 2011

    Report

    Report Number
    2124215-2011-06792
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    August 20, 2009
    Report Date
    February 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RESOLUTION TO THIS ISSUE WAS UNKNOWN. THE PATIENT WAS DISCUSSING BEING PLACED ON DNR/DNI. AT THE TIME OF THE EVEN THE TACHY MODE WAS STILL ON FOR THIS PATIENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D -H179) DETECTED NOISE ON THIS DEFIBRILLATION LEAD. THE NOISE IS REPRODUCIBLE WITH ISOMETRICS AND AT LEAST SENSITIVITY. THIS NOISE WAS OVERSENSED AND LED TO LESS THAN TWO BEATS OF PACING INHIBITION. LEAD MEASUREMENTS HAVE BEEN STABLE. IMPEDANCES IN THE 600 OHMS RANGE. A CHEST X-RAY WAS SUGGESTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. RESOLUTION WAS REQUESTED FROM THE FIELD. IT WAS REPORTED THAT THE PHYSICIAN HAS DECIDED TO WAIT FOR A GENERATOR CHANGE OUT. AN X-RAY HAS NOT BEEN PERFORMED AND THERE WERE NO ADVERSE PATIENT EFFECTS. THE H179 WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND THE NEW CRT-D (N119) WAS IMPLANTED. OVER FOUR MONTHS LATER, IT WAS REPORTED THAT THERE WERE LEAD FRACTURES AND INSULATION BREAK IN BOTH THE DEFIBRILLATION LEAD AND THE RIGHT ATRIAL LEAD. THE RA LEAD WAS NOT WORKING AT ALL AND HAD IMPEDANCES > 2000 OHMS. THE DEFIBRILLATION LEAD HAD ONGOING NOISE. THE PATIENT HAD RECEIVED 16 SHOCKS WHICH WERE REPORTED AS APPROPRIATE SHOCKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 6744| 4479| H175| H179| 0185| 4456| 4046| 1298