BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELIA S

    MDR report key: 5053623 · Received September 3, 2015

    Report

    Report Number
    9614453-2015-02162
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 12, 2015
    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 A PATIENT HAD PASSED AWAY. IT WAS ALSO REPORTED THE PATIENT'S DEVICE BATTERY WAS DEPLETING AND THAT ONE OF THE ASSOCIATED LEADS (MANUFACTURER UNKNOWN) WAS EXPERIENCING RISING AND HIGH THRESHOLDS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE AND WERE UNSUCCESSFUL. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584374 RELIA S PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND RES01

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Death UNKNOWN LEAD