BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2954062 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00230
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    April 20, 2012
    Report Date
    November 12, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 DEVICE COUNTER INCORRECTLY REPRESENTED THE PERCENTAGE OF PACED AND SENSED ATRIAL EVENTS. IT WAS ALSO NOTED THE ATRIAL LEAD IMPEDANCE WAS HIGH. THE PATIENT HAS PERMANENT ATRIAL FIBRILLATION AND THE PHYSICIAN STATED THE ATRIAL LEAD WAS NOT IMPLANTED. THE DEVICE PRINT OUT WAS REVIEWED AND IT WAS DISCOVERED THE DEVICE WAS PROGRAMMED INCORRECTLY. DURING THE PATIENT'S FOLLOW UP VISIT, REPROGRAMMING OF THE DEVICE WAS RECOMMENDED TO THE PHYSICIAN AND IT WAS NOTED THE DEVICE "WORKS PROPERLY". IT WAS ALSO REPORTED THE DEVICE WAS IMPLANTED AFTER THE USE BEFORE DATE. THE DEVICE REMAINS 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
    58503 MAXIMO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D284TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention