BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENRHYTHM

    MDR report key: 2988517 · Received March 4, 2013

    Report

    Report Number
    9614453-2013-00548
    Event Type
    Death
    Date Received
    March 4, 2013
    Date of Event
    April 20, 2012
    Report Date
    February 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    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).

    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, WHO WAS A PARTICIPANT IN THE (B)(4) STUDY, IS DECEASED. THE DEATH OCCURRED FIVE YEARS AND EIGHT MONTHS POST IMPLANT. THE CAUSE OF DEATH IS UNKNOWN. THE PHYSICIAN REPORTED NO COMPLAINT WITH 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
    91282 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death