BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2910783 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16593
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 THIS PATIENT'S DAUGHTER CALLED PATIENT SERVICES (PS) AND WAS QUESTIONING IF THIS DEVICE WAS ON ANY RECALL, AS HER FATHER WAS EXHIBITNG LOWER THAN NORMAL HEART RATES AND SYNCOPE WHICH LEAD HIM TO THE EMERGENCY ROOM (ER). PS SUGGESTED A FOLLOW UP VISIT WITH THE PHYSICIAN IS IN ORDER, AND THAT THE DEVICE WAS NOT ON ANY ADVISORY. THE PATIENT'S SYSTEM REMAINS IMPLANTED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16563 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 1280| 1298| 4457| 4568| 4076