BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS DR US

    MDR report key: 2161766 · Received April 29, 2011

    Report

    Report Number
    1028232-2010-02716
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    December 8, 2009
    Report Date
    December 8, 2009
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. THE BATTERY OF THE PACEMAKER WAS FOUND TO BE FULLY DEPLETED. THEREFORE, THE PACEMAKER'S PACING SIGNAL COULD NOT BE OBSERVED. A DESTRUCTIVE ANALYSIS CONFIRMED A FULLY DEPLETED BATTERY. CONNECTING AN EXTERNAL POWER SUPPLY, THE PACEMAKER SHOWED EXPECTED PACING AND SENSING SIGNALS. THERE WAS NO INDICATION OF SENDING AND/OR PACING PROBLEMS. THE ANALYSIS OF THE CURRENT CONSUMPTION SHOWED EXPECTED VALUES. ALSO THE CIRCUIT WAS FUNCTIONED CORRECTLY. THE COMPLAINT DESCRIPTION SHOWS AN ESTIMATED REMAINING SERVICE TIME WITH UNEXPECTED VALUES. HOWEVER, DESPITE OF THOROUGH ANALYSIS THE CLINICAL BEHAVIOR COULD NOT BE REPRODUCED. THE ESTIMATED SERVICE TIME FOR THIS PACEMAKER IS 66 MONTHS TO ERI FOR FACTORY SETTINGS WITH 100% STIMULATION. THE OBSERVED SERVICE TIME LIES WITH 115 MONTHS WELL ABOVE THE EXPECTED RANGE. IN SUMMARY, THE BATTERY PROVED TO BE DEPLETED. THE ANALYSIS CONFIRMED THAT THE DISPLAYED REMAINING SERVICE TIME WAS INACCURATE. DURING ANALYSIS THE CLINICAL BEHAVIOR WAS NOT REPRODUCIBLE.

    Description of Event or Problem · 1

    THIS DEVICE SHOWED 6 YRS 10 MONTHS REMAINING UNTIL ERI. BATTERY IMPEDANCE WAS 10 KOHMS AND VOLTAGE WAS 2.41. IT WAS RECOMMENDED TO EXPLANT AT THAT TIME AND SEND THE DEVICE IN FOR ANALYSIS. ON (B)(6) 2010 - THIS DEVICE WAS RETURNED AND IS AT ERI INDICATION AND HAS MET LONGEVITY ESTIMATES. THIS WAS EXPLANTED ON (B)(6) 2010 AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS DR US PACEMAKER NVZ BIOTRONIK SE & CO. KG 331443

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization