BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1870779 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17041
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE HAS BEEN DISPLAYING BATTERY STATUS FLUCTUATIONS. A MEASUREMENT WAS TAKEN WITH A PROGRAMMER THAT STATED THERE IS LESS THAN 6 MONTHS REMAINING. A MAGNET WAS APPLIED WHICH WAS AT 100 BPM INDICATING BEGINNING OF LIFE. SINCE THIS PATIENT IS PACEMAKER DEPENDANT, THE HEALTH CARE PRACTITIONER WAS CONCERNED THAT THE DEVICE WAS DEPLETING PREMATURELY. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 4016| S602| 1270| 4024| 7088| 1022T| 4018