BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4151866 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-06295
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 6, 2015
    Manufacturer
    ST JUDE MEDICAL, NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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.

    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 1 OF 3. REFERENCE MFR REPORTS: 1627487-2014-06296 & 1627487-2015-03314. ADDITIONAL HISTORICAL INFORMATION FROM THE MEDICAL CHART REVIEW IDENTIFIED THAT PRIOR TO EXPLANT THE PATIENT ALSO EXPERIENCED NOT BEING ABLE TO LIFT HIS ARM DUE TO THE TENSION AT THE SCS ANCHOR SITE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2013 DURING WHICH BOTH THE LEAD AND ANCHOR WERE REVISED WHICH RESOLVED THE ISSUE. ADDITIONALLY, IT WAS CLARIFIED THE PATIENT DEVELOPED A WARMING SENSATION IN THE LEFT SACRAL REGION WHILE USING STIMULATION FOR PROLONGED PERIODS. MOREOVER, THE PATIENT'S SCS SYSTEM WAS EXPLANTED PER THE PATIENT¿S REQUEST. THE SCS ANCHORS (SAME LOT) ARE BEING REPORTED AS DEVICE 3. ADDITIONAL INFORMATION IS NEEDED TO CLARIFY THE NATURE OF THE PATIENT'S ISSUES. THE PATIENT'S SCS SYSTEM WAS NOT EVALUATED BY AN SJM REPRESENTATIVE TO VERIFY AND/OR TROUBLESHOOT ANY OF THE REPORTED ISSUES PRIOR TO EXPLANT.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFER TO MFR REPORT 1627487-2014-06296. THE PT HAD TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. INFO PROVIDED BY THE PT'S ATTY INDICATED THAT THE PT ALLEGES THE FOLLOWING ISSUES: THE PT REPORTS HE EXPERIENCED "SEVERE POWER SURGES/SHOCKING," HEAT AND PAIN AT THE IMPLANT SITE (UNK SITE). THE PT'S ENTIRE SCS SYSTEM WAS REMOVED ON (B)(6) 2014. ADDITIONAL INFO IS NEEDED TO CLARIFY THE NATURE OT THE PT'S ISSUES. THE PT'S SCS SYSTEM WAS NOT EVALUATED BY AN SJM REP TO VERIFY AND/OR TROUBLESHOOT ANY OF THE REPORTED ISSUES PRIOR TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622946 EON MINI SCS IPG GZB ST JUDE MEDICAL, NEUROMODULATION 3788 3907698

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other SCS ANCHOR: MODEL 1192 (2),| IMPLANT DATE: