BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 6028817 · Received October 13, 2016

    Report

    Report Number
    1627487-2016-05346
    Event Type
    Injury
    Date Received
    October 13, 2016
    Report Date
    September 19, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL #S: 1627487-07262012-002-R; 162487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE PATIENT EXPERIENCED DIFFICULTY RECHARGING HER IPG AND HER PROGRAMMER REFLECTED A 'LOW BATTERY' ERROR MESSAGE. LATER, THE PATIENT WAS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER IPG AND EXTERNAL DEVICES. THE PATIENT'S IPG WAS INOPERABLE. AS SUCH, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE IPG WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL. EFFECTIVE THERAPY WAS ACHIEVED POST-OPERATIVE AND THE ISSUE IS NOW RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677069 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2841437

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3219, SCS LEAD