BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3212558 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08884
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RIGHT VENTRICULAR (RV) THRESHOLD TEST, CAPTURED APPEARED TO BE LOST AT 0.9 VOLTS, HOWEVER, THE TEST CONTINUED TO 0.7 VOLTS. NO FLAT LINE OBSERVED ON THE PROGRAMMER SCREEN AND NO BACK UP PACING OBSERVED, HOWEVER, NO PAPER WAS RUN DURING THE TEST. NO APPARENT OVERSENSING WAS OBSERVED. THE DEVICE WAS PROGRAMMED TO A FIXED OUTPUT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312360 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR S603| 4135| 4136