BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2911982 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00419
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 1, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    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 IMPLANT SITE JUMPS EVERY FIVE MINUTES OR SO. THE PATIENT INTERROGATED THEIR DEVICE AND WANTED TO KNOW THE RESULTS. THE PATIENT WAS ADVISED TO CONTACT THEIR CARDIOLOGIST ABOUT THE DATA. THE PATIENT ALSO MENTIONED THAT THEIR DEVICE HAD PREVIOUSLY MALFUNCTIONED A WHILE BACK AND IT HAD TO BE ADJUSTED BECAUSE THEIR HEART WAS RACING. NO FURTHER INFORMATION ABOUT THIS EVENT WAS AVAILABLE THROUGH ANY COMPANY REPRESENTATIVE OTHER THAN THAT THE PATIENT HASN'T BEEN SEEN BY THEIR CLINIC IN MANY YEARS. DUE TO THE MALFUNCTION, IT CANNOT BE REFUTED THAT THIS PRIOR EVENT COULD BE SEEN AS LIFE THREATENING IN ANOTHER SITUATION. AS OF TODAY, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18378 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1198

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR 1198| 1184| 292-03| 4087| 430-07