BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II VR

    MDR report key: 4960352 · Received August 3, 2015

    Report

    Report Number
    9614453-2015-01642
    Event Type
    Death
    Date Received
    August 3, 2015
    Date of Event
    June 21, 2015
    Report Date
    July 9, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. PATIENT DEATH GEO EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT, WITH MAXIMO II VR DEVICE, PASSED AWAY AROUND (B)(6). THE PATIENT COULD HAVE DIED DUE TO SEVER GASPING AND BREATHLESSNESS WHEN HE REACHED HOSPITAL AND SUDDENLY DIED. IT WAS QUESTIONED WHAT COULD HAVE BEEN THE REASON FOR DEATH OF THIS PATIENT WHILE PATIENT WAS HAVING DEVICE. THE DEVICE WAS NOT SWITCHED OFF AT THE TIME OF EXPLANT. PRELIMINARY GEO ASSESSMENT: REVIEW OF STD ((B)(6) 2015) REVEALED: THIS PATIENT WAS NOT PACING DEPENDENT (0% PACING/DAY). PACING STARTED ON (B)(6) 2015 AT APPROXIMATELY 4:56 H. ONE SHOCK WAS SUCCESSFULLY DELIVERED AT 4:28 H. MULTIPLE NON-SUCCESSFUL SHOCKS WERE DELIVERED AT 4:57 H. EGM RECORDINGS WERE OVER-WRITTEN AND CANNOT BE RECOVERED. NO PATIENT ALERTS: NORMAL IMPEDANCES PRELIMINARY GEO CONCLUSION: SUSPECT SYSTEM OK (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY EIGHT MONTHS AFTER IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT PRESENTED WITH "SEVERE GASPING AND BREATHLESSNESS WHEN HE REACHED HOSPITAL AND SUDDENLY DIED." THE EXACT CAUSE OF DEATH WAS REQUESTED BUT REMAINS UNCLEAR. IT WAS NOTED THAT DEVICE DETECTIONS WERE NOT TURNED OFF AT THE TIME OF DEVICE EXPLANT, OVER-WRITING DEVICE DATA THAT WAS RECORDED AT THE TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504163 MAXIMO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death