BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1890002 · Received November 3, 2010

    Report

    Report Number
    2124215-2010-21250
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    May 26, 2009
    Report Date
    August 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, IT WAS NOTED THAT SHOCK IMPEDANCE MEASUREMENTS HAVE BEEN TRENDING DOWN. THIS WAS OBSERVED DURING A DEVICE CHECK PRIOR TO RADIATION THERAPY, WHERE SHOCK IMPEDANCE MEASUREMENTS WERE IN THE 85 OHM RANGE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS OBSERVATION. AVAILABLE INFORMATION SUGGESTS THAT THESE PRODUCTS REMAINS IN SERVICE, WITH THE SHOCK IMPEDANCE CONTINUING TO BE MONITORED. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN INCREASED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WAS OBSERVED ONCE AGAIN ON THIS DEVICE SYSTEM. THE LOCAL BOSTON SCIENTIFIC SALES REPRESENTATIVE REPORTED THAT THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM RECENTLY ENDURED A NON-DEVICE RELATED PROCEDURE AND WAS RECOVERING. FOLLOWING RECOVERY, THE PATIENT'S CARDIOLOGIST PLANS TO BRING THE PATIENT IN FOR A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) PROCEDURE TO TEST THE HIGH VOLTAGE SHOCK INTEGRITY OF THE DEVICE SYSTEM. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TRANSVENOUS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCE MEASUREMENTS FROM 77 OHMS AT IMPLANT, TO ONE MEASUREMENT OF GREATER THAN 125 OHMS. NO NOISE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR T177| 0181