BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1953605 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24081
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONFIRMED THE MAGNET RATES FOR THIS DEVICE AND OFFERED TO CONSULT WITH A COLLEAGUE FOR TROUBLESHOOTING. SINCE THE PATIENT WAS NOT IN THE OFFICE, THE CALLER DECLINED AND STATED HE WOULD CALL BACK WITH ANY FURTHER INFORMATION OR QUESTIONS. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS NURSE CALLED TECHNICAL SERVICES (TS) STATING THIS DEVICE MAGNET RATE WAS AT 85. HE WANTED TO CONFIRM THE ELECTIVE REPLACEMENT TIME (ERT) TRIGGER RATE WAS 85 AND NOTED CONCERN WITH PREMATURE BATTERY DEPLETION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR (B)(4)| S603