BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY II

    MDR report key: 1862234 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-18898
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH DEVICE EVALUATION WAS PERFORMED. NORMAL PACING AND SENSING WAS CONFIRMED. NO NOISE OR PAUSES IN PACING WERE OBSERVED DURING ADDITIONAL TESTING WHILE THE DEVICE WAS MANIPULATED. FINAL DEVICE EVALUATION WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS. 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 CRM RECEIVED INFORMATION THAT THIS PATIENT PRESENTED WITH A STROKE AND A MYOCARDIAL INFARCTION (MI). SYSTEM EVALUATION NOTED NOISE ON THE RIGHT VENTRICULAR CHANNEL WHICH WAS OVERSENSED AND RESULTED IN PACING INHIBITION AND A FOUR SECOND PAUSE IN PACING FOR THIS PACEMAKER DEPENDENT PATIENT. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT REVIEWED THE SYSTEM EGMS AND SUSPECTS SOME ELECTROMAGNETIC INTERFERENCE (EMI). THE CALLER REPROGRAMMED THE RIGHT VENTRICULAR SENSITIVITY TO 10 MV AND HAS WATCHED THE PATIENT TO SEE IF ANY FURTHER INHIBITION OCCURRED; WHICH HAS NOT TO THIS POINT. THE CALLER WILL DISCUSS THE CLINICAL OBSERVATIONS WITH THIS PATIENT'S PHYSICIAN. ONE MONTH LATER, THIS PACEMAKER AND RIGHT VENTRICULAR LEAD WERE REMOVED FROM SERVICE AND REPLACED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1284

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 4087| 1135| 1284| 0523| 4116| 4086