BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1870805 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17241
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS REPORT, ALL PRODUCTS REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT REPORTED A STABBING PAIN IN HIS LEFT SIDE WHILE DOING YARD WORK. HE STATES HE HAD AN INFECTION AFTER HIS DEVICE WAS IMPLANTED, HOWEVER EXPLAINED THE CURRENT SYMPTOMS FEEL DIFFERENT AND THE PAIN CHANGES WITH MOVEMENT. THE PATIENT WAS REFERRED TO THEIR PHYSICIAN. OUR COMPANY HAS NO RECORD OF A PREVIOUS INFECTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other 4136| 4137| 1291