BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSAR MAX

    MDR report key: 2151390 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07314
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED ATR AND FALLBACK MODE DETAILS WITH THE CALLER. THE CONSULTANT EXPLAINED THAT THE ENTRY CRITERIA MUST NOT HAVE BEEN MET AND THE RATE SLOWED DOWN BUT DID NOT MEET EXIT CRITERIA BEFORE THE MODE SWITCH OCCURRED. THE CALLER PERFORMED ISOMETRICS AND POCKET MANIPULATION AND ALL PARAMETERS REMAINED WITHIN NORMAL LIMITS. THE TEST RESULTS WERE PROVIDED TO THE PATIENT'S CARDIOLOGIST. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD EXPERIENCED A SYNCOPAL EPISODE WHILE EATING BREAKFAST. EVALUATION OF THE SYSTEM IN THE EMERGENCY ROOM NOTED THE PATIENT'S RATE WAS STABLE AT 80-85 BPM. THE CALLER DID REPORT SOME ATRIAL TACHY RESPONSE (ATRS) WITH NOISE ON THE EGMS. THE CALLER WAS ASKING WHY THE DEVICE DID NOT GO INTO FALLBACK MODE. IMPEDANCE MEASUREMENTS HAVE BEEN WITHIN NORMAL LIMITS AT 400-500 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1270

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)