BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 2811838 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02438
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    December 6, 2005
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A DEVICE POCKET INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY AND THE INFECTION RESOLVED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7298

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention