BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3052667 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04123
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    August 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    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

    THE DEVICE WAS LATER EXPLANTED FOR AN UNSPECIFIED REASON AND RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS PROGRAMMED WITH NOMINAL SETTINGS, RESULTING IN BATTERY DEPLETION. 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 DEVICE DECLARED ELECTIVE REPLACEMENT TIME (ERT) IN LESS THAN THREE YEARS FOR AN UNSPECIFIED REASON. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, ADDITIONAL INFORMATION WAS NOT AVAILABLE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154678 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR S603| 4135| 4136