BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4091871 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-02589
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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 LOST STIMULATION THERAPY FROM HIS SCS SYSTEM TWO WEEKS AGO, AND HE IS UNABLE TO COMMUNICATE WITH HIS IPG AND EXTERNAL DEVICES. THE PATIENT STATED HE LAST CHARGED HIS IPG APPROXIMATELY THREE WEEKS AGO. A REPLACEMENT CHARGER SENT TO THE PATIENT DID NOT RESOLVE THE ISSUE. A SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE PATIENT'S IPG IS INOPERABLE. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526715 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2884611

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3219