BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1771539 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12745
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 12, 2010
    Report Date
    June 12, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED SYNCOPAL EPISODES OF AN UNKNOWN ETIOLOGY. THE PATIENT'S PACEMAKER WAS INTERROGATED AND IT WAS REPORTED THAT THE PACEMAKER WAS FUNCTIONING NORMALLY AND THERE WAS NO VENTRICULAR TACHYCARDIA (VT) EVENTS OBSERVED IN THE DEVICE MEMORY. THE PATIENT WILL CONTINUE TO BE MONITORED AND NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening 1297| 4271| (B)(4)| 1276