BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3961304 · Received July 18, 2014

    Report

    Report Number
    1627487-2014-03486
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    November 3, 2011
    Report Date
    March 16, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    CORRECTION/REMOVAL NUMBER: 1627487-12192011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 2 REFERENCE MFR. REPORT: 1627487-2015-03140 ADDITIONAL HISTORICAL INFORMATION FROM THE MEDICAL CHART REVIEW IDENTIFIED THAT PRIOR TO EXPLANT, THE PATIENT EXPERIENCED MULTIPLE INFECTIONS AT THE LEAD AND IPG POCKET SITES WHICH RESULTED IN MULTIPLE SURGERIES, MULTIPLE HOSPITALIZATIONS AND INTRA-VENOUS ANTIBIOTIC TREATMENT. THE PATIENT EXPERIENCED : A (B)(6) INFECTION AT THE UPPER THORACIC WOUND AREA AND WAS HOSPITALIZED ON (B)(6) 2011. AS A RESULT, THE PATIENT UNDERWENT WOUND DEBRIDEMENT AND DRAINAGE ON (B)(6) 2011 AND WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2011. NEXT, IT WAS IDENTIFIED THAT LAB DIAGNOSTICS WERE (B)(6) FOR (B)(6) ON (B)(6) 2011. IT WAS ALSO REPORTED THE PATIENT RECEIVED ANTIBIOTICS. ADDITIONALLY, IT WAS CLARIFIED THE PATIENT'S SCS IPG WAS REPOSITIONED ON (B)(6) 2011. FURTHERMORE, THE SCS IPG WAS EXPLANTED (PREVIOUSLY REPORTED WITHIN INITIAL REPORT) AS A RESULT OF CHRONIC INFECTION-(B)(6) (DATE OF DIAGNOSIS (B)(6) 2011 PATIENT WAS HOSPITALIZED ON (B)(6) 2011). MOREOVER, IT WAS IDENTIFIED THE PATIENT'S SCS LEAD WAS EXPLANTED ON (B)(6) 2013 DUE TO A MASS AND PAIN ALONG THE LEAD SITE. AS OF (B)(6) 2013, THE INFECTION AND PAIN HAD RESOLVED. THE SCS LEAD IS BEING REPORTED AS DEVICE 2. ADDITIONAL INFORMATION IS NEEDED TO CLARIFY THE NATURE OF THE PATIENT'S ISSUES. SJM WAS MADE AWARE OF THE ISSUES ON (B)(6) 2015, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AND A BURNING SENSATION AT HIS SCS IPG POCKET SITE (NOT RELATED TO CHARGING). AN SJM REPRESENTATIVE WAS UNABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING. AS A RESULT, THE PATIENT'S SCS SYSTEM WAS EXPLANTED. 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-RELATED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED. DUE TO THE NATURE OF LITIGATION THESE ALLEGATIONS CANNOT BE CONFIRMED OR REJECTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421149 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3240783

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3228