BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II VR

    MDR report key: 3872328 · Received June 13, 2014

    Report

    Report Number
    9614453-2014-01511
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 20, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 LEAD DISLODGED THE DAY AFTER DEVICE SYSTEM IMPLANT. THE LEAD WAS RE-IMPLANTED AND THE PATIENT IS REPORTED TO HAVE BEEN FINE AFTERWARDS WITH ELECTROGRAMS SHOWING PACING HEART RATE. ONE MONTH LATER IT WAS NOTED THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. THE FAMILY HAS ALLEGED THE DEVICE DID NOT WORK AROUND THE TIME OF THE PATIENT¿S DEATH AND THAT THE PATIENT HAD NO BREATH OR HEART BEAT WHEN WAS SENT TO THE HOSPITAL FOR RESUSCITATION. NO AUTOPSY WAS PERFORMED AND THE DEVICE WILL NOT BE RETURNED. NO ELECTROGRAMS WERE RETAINED BY THE HOSPITAL FOLLOWING THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349202 MAXIMO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death UNKNOWN LEAD