BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 2913108 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16935
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS NOT EVALUATED IN THE CLINIC AND THE CAUSE OF THE SYNCOPAL EVENT HAS NOT BEEN DETERMINED. THE PATIENT HAS SUBMITTED SOME BENIGN EVENT RECORDER TRACINGS SINCE (B)(6) AND THE CLINIC FEELS THAT THERE WAS NO REASON TO SUSPECT THE DEVICE CAUSED OR CONTRIBUTED TO THE SYNCOPAL EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER EXPERIENCED A FAINTING SPELL AND LOST CONSIOUSNESS. THIS WAS A ONE TIME OCCURRENCE AND HAS NOT HAPPENED AGAIN. THE PATIENT ALSO REPORTS THAT THEY OCCASIONALLY EXPERIENCE FLUTTERING SENSATIONS FROM THE DEVICE. THE CLINIC IS AWARE AND HAS THE PATIENT WEARING A HOLTER MONITOR. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20842 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K172

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening K172| 4137