BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4093593 · Received September 4, 2014

    Report

    Report Number
    1627487-2014-06259
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    December 12, 2011
    Report Date
    March 9, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C;
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND A FIELD CORRECTION. SSM 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. REPORT: 1627487-2014-06260, 1627487-2014-06261. THE PATIENT HAD TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY, INDICATED THE PATIENT ALLEGES THE FOLLOWING ISSUES: THE PATIENT EXPERIENCED BURNING WHILE CHARGING, SHOCKING AND INCREASED RECHARGE BURDEN. PATIENT FELT THE BURNING AT HIS IPG AND LEAD SITES. THE SHOCKING OCCURRED WHILE THE DEVICE WAS ON AND WHEN PATIENT WOULD MOVE A CERTAIN WAY. THE PATIENT'S ENTIRE SCS SYSTEM WAS REMOVED (B)(6) 2011. ADDITIONAL INFORMATION IS NEEDED TO CLARIFY THE NATURE OF THE PATIENT'S ISSUES. SJM WAS MADE AWARE OF THE ISSUES ON (B)(4) 2014, AND 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. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2014-06260, REFERENCE MFR REPORT: 1627487-2014-06261. THE FOLLOWING INFORMATION WAS PROVIDED AFTER A REVIEW OF THE PATIENT¿S MEDICAL CHART: ON (B)(6) 2011, THE PATIENT REPORTED EXPERIENCING PAIN AND SWELLING AT THE IPG SITE WITH BRUISING TO THE RIGHT HIP. THE PATIENT WAS TREATED WITH LIDOCAINE OINTMENT AND PATCHES. ON (B)(6) 2011, THE PATIENT REPORTED PAIN AT THE LEAD SITE. EXAM REVEALED SLIGHT TENDERNESS ALONG THE ANCHOR SITE IN THE BACK. ON (B)(6) 2011, THE PATIENT SOUGHT TREATMENT IN AN ER. HE WAS SHAKING, SWEATING, SICK AND DRAWING UP OF THE NECK MUSCLES WITH SPASMS. HE ALSO REPORTED NAUSEA, DECREASED APPETITE (HADN¿T EATEN IN 2 DAYS), DIAPHORESIS AND INCREASED BACK PAIN. HE WAS TREATED WITH DIAZEPAM AND ONDANSETRON. ON (B)(6) 2011, THE PATIENT REQUESTED TO HAVE HIS SCS SYSTEM REMOVED DUE TO PAIN AT BOTH THE LEAD AND IPG SITES. THE PATIENT HAD OBVIOUS WEIGHT LOSS AND THE PHYSICIAN COULD PALPATE THE GENERATOR PROMINENTLY AND COULD SEE IT THROUGH THE SKIN. THE PATIENT COMPLAINED OF DIFFUSE THORACIC, LUMBAR AND ABDOMINAL PAIN AS WELL, WHICH WAS NOT PART OF HIS ORIGINAL SYMPTOMS. CT OF THE LUMBAR AND THORACIC SPINE REVEALED DISC PROTRUSION AT L3-4 AS WELL AS A MODERATE SIZED BROAD-BASED DISC PROTRUSION AT T10-11 ON THE RIGHT. THE PHYSICIAN INFORMED THE PATIENT THAT HIS DISC HERNIATION AT T10-11 WAS MOST LIKELY THE CAUSE OF THE BACK AND IPG SITE PAIN AND THERE WAS NOT MUCH THAT COULD BE DONE FOR HIS NEUROPATHIC PAIN. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE HIS ENTIRE SCS SYSTEM WAS EXPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542180 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3136266

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: