BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III MARQUIS

    MDR report key: 2788356 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02213
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 20, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. 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 LIMITED DUE TO CONFIDENTIALITY CONCERNS. MOMOMURA SI, TSUTSUI H,SUGAWARAY,ETAL. CLINICAL EFFICACY OF CARDIAC RESYNCHRONIZATION THERAPY WITH AN IMPLANTABLE DEFIBRILLATOR IN A JAPANESE POPULATION -RESULTS OF THE MIRACLE-ICD OUTCOME MEASURED IN JAPANESE INDICATION (MOMIJI) STUDY. CIRC. J. AUGUST 9 2012; 76(8):1911-1919.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR. THE FAILURE MODES NOTED IN THE ARTICLE WERE INAPPROPRIATE DETECTIONS AND/OR PATIENTS THOSE INAPPROPRIATE DETECTIONS LED TO INAPPROPRIATE SHOCKS. FOLLOW UP DID NOT YIELD ANY INTERVENTIONS THAT MAY HAVE OCCURRED OR THE STATUS OF THE DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III MARQUIS IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7279

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R