BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3211072 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07697
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DURING A GASTROENTEROLOGICAL OPERATION, THE PATIENT EXPERIENCED FOUR SECONDS OF ASYSTOLE. THERE WAS ALSO A SIGNIFICANT DROP IN THE PATIENT'S BLOOD PRESSURE DURING THAT TIME. THE DEVICE WAS CHECKED AND CONFIRMED TO BE FUNCTIONING APPROPRIATELY. IT WAS INDICATED THAT THERE WAS NO USE OF EQUIPMENT THAT COULD HAVE INTERACTED WITH THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310935 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening