BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 3153440 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01141
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 21, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO WORSENING HEART FAILURE. DURING THE HOSPITALIZATION, FAST VENTRICULAR TACHYCARDIA (VT) EPISODES OCCURRED, BUT THE DEVICE DID NOT DELIVER THERAPY. THE VT WAS TERMINATED BY EXTERNAL DEFIBRILLATION. PATIENT UNDERWENT SERIOUS DECOMPENSATION DUE TO THIS EPISODE. IT WAS SURMISED THERAPY WAS NOT PROVIDED SINCE THE EPISODES THAT OCCURRED WERE ON THE EDGE OF THE VT DETECTION INTERVAL AND VT DETECTION WAS ABORTED/NON-SUSTAINED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256681 INSYNC MAXIMO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND 7304

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R