BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2920860 · Received January 17, 2013

    Report

    Report Number
    2124215-2013-01146
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    May 1, 2012
    Report Date
    January 29, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED. DURING THE EXPLANT PROCEDURE, NON-INVASIVE PROGRAMMED STIMULATION (NIPS) OF THE RIGHT VENTRICULAR (RV) LEAD WAS PERFORMED AND SHOWED NORMAL SHOCK IMPEDANCE MEASUREMENTS. THE LEAD REMAINS IMPLANTED WITH NO CHANGE. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT DEVICE CHECK, A REVIEW OF THE DAILY MEASUREMENTS SHOWED OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS AT OR OVER 125 OHMS. A RAPID DEPLETION OF THE DEVICE'S BATTERY WAS ALSO OBSERVED. A SAVE TO DISC WAS PERFORMED AND SENT IN FOR ANALYSIS. UPON REVIEW OF THE DATA IN THE MEMORY DUMP BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS), SHOWED A HIGH POWER CONSUMPTION OF GREATER THAN 100UW CONSUMPTION BEING DISPLAYED. THE HIGH POWER CONDITION APPEARS TO HAVE BEGAN 8 MONTHS PREVIOUS., BEFORE WHICH THE OPERATING POWER LEVELS APPEARED TO BE NORMAL. THE POWER WAS NOTED STEADY AT APPROXIMATELY 170UW FOR SEVERAL MONTHS, MORE RECENTLY FLUCTUATED TO LOWER VALUES. SINCE A DETERMINATION OF THE CAUSE FOR THE HIGH POWER MEASURES CANNOT DETERMINE IT WAS DISCUSSED TO REPLACE THE DEVICE AND HAVE IT SENT IN FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. A REQUEST FOR ADDITIONAL INFORMATION AND DEVICE STATUS HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27064 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 0180| E102