BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3241477 · Received July 22, 2013

    Report

    Report Number
    2124215-2013-11513
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IS REQUESTED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER'S MAGNET RATE WAS AT 90 BEATS PER MINUTE. THE DEVICE WAS IMPLANTED THREE YEARS AGO. ALL OTHER BATTERY INDICATORS WERE NORMAL. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED ABOUT RECOMMENDATIONS REGARDING A PREMATURE BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339986 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT PUERTO RICO BV S602

    Patients

    Seq Age Sex Outcome Treatment
    1