BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 7701238 · Received July 18, 2018

    Report

    Report Number
    1627487-2018-06623
    Event Type
    Injury
    Date Received
    July 18, 2018
    Date of Event
    December 31, 2013
    Report Date
    July 18, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05414734402651
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S CONCOMITANT MEDICAL PRODUCTS AND DATES ARE UNKNOWN. RECALL CONTINUED: 1627487-07262012-002-R; 162748-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    IT WAS REPORTED THE PATIENT'S IPG "STOPPED WORKING" IN 2013 AND THERAPY HAS BEEN OFF SINCE THAT TIME. AS SUCH, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542979 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 172867 05414734402651

    Patients

    Seq Age Sex Outcome Treatment
    1 Other