BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3210237 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06779
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 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

    AS OF TODAY, THE DEVICE AND COMPETITIVE LEAD REMAIN IN SERVICE. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND THE COMPETITIVE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AT 6.5V @ 1.0MS. THE RV PACING IMPEDANCE MEASUREMENT WAS NORMAL, WHILE THE R-WAVE MEASUREMENTS HAD DECREASED. THE PATIENT¿S PACING RATE WAS 14%, SO THE PATIENT RECEIVED A HOLTER MONITOR. THE PHYSICIAN WILL DETERMINE WHETHER A REPLACEMENT PROCEDURE OR DEVICE REPROGRAMMING WILL BE PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309136 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1