BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3850558 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-02368
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 30, 2013
    Report Date
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 1 OF 3. REF MFR REPORTS # 1627487-2014-02369, 1627487-2014-02370. IT WAS REPORTED THAT AFTER THE PT HAD AN UNRELATED SPINAL FUSION SURGERY SHE COULD NOT FEEL THE SCS SYSTEM STIMULATION ALTHOUGH HER IPG DISPLAYED STIMULATION AS WORKING. PT WAS INSTRUCTED BY TECHNICAL SERVICES TO SWITCH PROGRAMS AND INCREASE STIMULATION. PT WAS THEN ABLE TO FEEL STIMULATION IN HER LEGS INSTEAD OF HER MID TO LOW BACK WHERE IT IS NEEDED. AN SJM REPRESENTATIVE MET WITH THE PT BUT WAS UNABLE TO RECAPTURE EFFECTIVE STIMULATION IN THE CORRECT LOCATION. IN ADDITION, LOW IMPEDANCES WERE OBSERVED DURING THE REPROGRAMMING ATTEMPT. THE PT IS PENDING A CONSULT WITH HER PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317182 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3439173

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other