BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLAIM 5 ELITE

    MDR report key: 7317883 · Received March 6, 2018

    Report

    Report Number
    1627487-2018-02215
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    February 7, 2018
    Report Date
    June 25, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487/09/12/2017/001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CONFIRMED THE ISSUE WAS RESOLVED AFTER THE WIRELESS SOFTWARE UPDATE WAS PERFORMED CLEARING THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. THE DEVICE IS PROVIDING THERAPY.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION IDENTIFIED THE PATIENT IS NO LONGER RECEIVING THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED RECEIVING THE ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT'S DEVICE IS PENDING ASSESSMENT BY A REPRESENTATIVE TO DETERMINE IF THE DEVICE IS OPERATING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160466 PROCLAIM 5 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3660 5573614

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR