BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 4813539 · Received June 2, 2015

    Report

    Report Number
    1627487-2015-23318
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 12, 2015
    Report Date
    January 13, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER IPG AND EXTERNAL DEVICES. I WAS ALSO REPORTED THE PATIENT HAS NOT RECHARGED HER IPG IN APPROXIMATELY EIGHT MONTHS. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE ISSUE. THE PATIENT MAY UNDERGO SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION REVEALED THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE HER IPG WAS EXPLANTED AND REPLACED WITH A DIFFIERENT MODEL. THERAPY WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356425 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3716872

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other MODEL 1192, SCS ANCHOR