BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3053131 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05145
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE. 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 THIS PACEMAKER AND THIS COMPETITIVE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INTERMITTENT LOSS OF CAPTURE. THE DEVICE WAS PROGRAMMED WITH AUTOMATIC CAPTURE ON, AND PACING FAILURE WAS OBSERVED ON THE ELECTROGRAMS (EGMS). ASYSTOLE OF 7.2 SECONDS WAS RECORDED. THE DEVICE APPEARED TO BE IN RETRY MODE, AS THE OUTPUT HAD SUSPENDED AT 3.8V AND NO BACKUP PACING WAS DELIVERED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT REVIEWED THE EGMS AND CONFIRMED THE DEVICE WAS OPERATING IN RETRY MODE. IN THE DAILY MEASUREMENTS, THE PACING THRESHOLD MEASUREMENTS WERE 1.3V TO 2.5V. THE PATIENT WAS SEEN IN THE CLINIC FOR EVALUATION. IT WAS OBSERVED THAT WHEN THE PATIENT LAY ON HIS LEFT SIDE, THE PACING THRESHOLDS INCREASED. THE DEVICE OUTPUT WAS REPROGRAMMED TO 5.0V. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155181 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1