BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3954940 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-21487
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 3 OF 3. REFER TO MFR REPORTS 1627487-2014-21486, 1627487-2014-21485. THE PATIENT RECEIVED TWO OCCIPITAL (OFF-LABEL) LEADS. IT WAS REPORTED THAT THE PATIENT (B)(6) EXPERIENCED LOSS OF STIMULATION POST-OPERATIVELY. DIAGNOSTICS INDICATED LOW AND INVALID IMPEDANCES ON THE LEFT LEAD. REPROGRAMMING WAS UNSUCCESSFUL AS THE PATIENT ONLY RECEIVED STIMULATION AT THE TOP OF HER SPINE. X-RAYS CONFIRMED BOTH OF THE LEADS HAD MIGRATED. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416031 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 4427689

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANT DATE:| SCS ANCHOR: MODEL 1194,