BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYNC SENTRY

    MDR report key: 1924444 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02261
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 28, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD AN OPTIVOL EVENT. INTERROGATION REVEALED THAT CARDIAC COMPASS DATA WAS INCORRECT FROM DAY 1. DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other