BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY

    MDR report key: 1864102 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15984
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 4, 2010
    Report Date
    September 23, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-1032-05 THRU Z-1039-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE PACEMAKER HAS NOT BEEN RETURNED. IF THIS PACEMAKER SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS EVENT WILL BE REOPENED AND UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED AND A MAGNET RATE COULD NOT BE OBTAINED. THE PATIENT HAD BEEN LOST TO FOLLOW UP AND THE DEVICE HAD BEEN IMPLANTED FOR 11 YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED AND A MAGNET RATE COULD NOT BE OBTAINED. THE PATIENT HAD BEEN LOST TO FOLLOW UP AND THE DEVICE HAD BEEN IMPLANTED FOR 11 YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1273

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 4476| 4003M| 4462| 8419| 1273