BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4060853 · Received August 6, 2014

    Report

    Report Number
    1627487-2014-02542
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFO 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2014-02543 AND REFERENCE MFR REPORT: 1627487-2014-02544. IT WAS REPORTED THE PATIENT HAS NOT USED OR CHARGED HER SCS IPG IN APPROXIMATELY A YEAR BECAUSE "SHE DID NOT LIKE THE THERAPY". IN ADDITION, THE PATIENT REPORTED SHE IS EXPERIENCING PAIN DUE TO SENSITIVITY AT THE SCS LEAD ANCHOR SITE. THE PATIENT STATED SHE WOULD LIKE TO HAVE HER SCS SYSTEM REMOVED. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461052 EON MINI SCS IPG GZB ST. JUDE MEDICAL, NEUROMODULATION 3788 2865284

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other