BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3052714 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04685
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 27, 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 THE PATIENT IMPLANTED WITH THIS PACEMAKER UNDERWENT AN UNRELATED PROCEDURE. WHILE IN POST OPERATIVE RECOVERY, THE PATIENT'S PACED RATE WAS OBSERVED TO INTERMITTENTLY JUMP TO APVP AT 90-100 BEATS PER MINUTE (BPM) AND THEN WOULD RESOLVE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POTENTIAL INTERACTION WITH THE MINUTE VENTILATION FEATURE (MV) AND RECOMMENDED TURNING MV OFF UNTIL THE PATIENT COMES OFF OF MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156166 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR S603| 4136| 4137