BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELIA S

    MDR report key: 3827567 · Received May 22, 2014

    Report

    Report Number
    9614453-2014-01045
    Event Type
    Death
    Date Received
    May 22, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    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 PATIENT IMPLANTED WITH AN IMPLANTABLE PULSE GENERATOR (IPG) DIED OF AN UNKNOWN CAUSE IN ANOTHER HOSPITAL ONE DAY FOLLOWING THE IMPLANT PROCEDURE. THERE WAS NO AUTOPSY REPORT AND NO FURTHER INFORMATION IS KNOWN. IT WAS NOTED THAT THE PHYSICIAN MENTIONED THERE WAS NO DEVICE PACING SIGNAL WHEN THE PATIENT DIED AND SUSPECTS THAT DEVICE WAS NOT WORKING AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305643 RELIA S PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND RES01

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death