BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II CRT-D

    MDR report key: 5036009 · Received August 27, 2015

    Report

    Report Number
    9614453-2015-02154
    Event Type
    Death
    Date Received
    August 27, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 31, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT MEDICAL PRODUCTS: MEDTRONIC UNKNOWN LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY 7 MONTHS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. IT WAS NOTED THAT 5 DAYS PRIOR TO DEATH THE PATIENT PRESENTED WITH SYNCOPE, MALAISE AND DYSPNEA. AT THAT TIME IT WAS NOTED THAT THE PATIENT WAS IN ATRIAL FLUTTER AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY WAS LOW. THE PATIENT WAS ADMITTED FOR CARDIOVERSION AND DEVICE REPLACEMENT (IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED RECENT ELECTRICAL STORMS). SUBSEQUENTLY THE ICD DELIVERED A 25J SHOCK WHICH SUCCESSFULLY CONVERTED THE RHYTHM. SHORTLY THEREAFTER, THE PATIENT HAD NO PULSE AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. THE PATIENT HAD RESPIRATORY ALKALOSIS, HYPOTENSION, PULMONARY EDEMA AND HEMODYNAMIC INSTABILITY AND SUBSEQUENTLY DIED. CAUSE OF DEATH REPORTED WAS CARDIOGENIC SHOCK DUE TO HEART FAILURE. IT WAS UNKNOWN IF THE DEATH WAS RELATED TO THE ICD SYSTEM. IT WAS ALSO NOTED THAT DURING THE DAY THE ICD DELIVERED SEVERAL SHOCKS WHICH WERE UNSUCCESSFUL AT CONVERTING THE RHYTHM. IT WAS REPORTED THAT THE DEVICE WAS OPERATING NORMAL AT THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE PATIENT WAS ENROLLED IN THE IMPROVE SUDDEN CARDIAC ARREST CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568945 MAXIMO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D284TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Death