BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENRHYTHM MRI

    MDR report key: 2978858 · Received February 26, 2013

    Report

    Report Number
    9614453-2013-00523
    Event Type
    Death
    Date Received
    February 26, 2013
    Date of Event
    September 4, 2010
    Report Date
    January 31, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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, WHO WAS A PARTICIPANT IN THE (B)(6) STUDY, IS DECEASED. THE DEATH OCCURRED ONE YEAR FOUR MONTHS POST IMPLANT. THE CAUSE OF DEATH IS UNKNOWN. THE PHYSICIAN DID NOT HAVE A COMPLAINT RELATED TO THE DEVICE. THE ADVERSE EVENT COMMITTEE OF THE STUDY CLASSIFIED THE RELATEDNESS OF THE ADVERSE EVENT TO THE PROCEDURE OR DEVICE AS "UNKNOWN" AND THE DEATH HAS BEEN CLASSIFIED AS "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82289 ENRHYTHM MRI PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND EMDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Death