BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4091973 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-06253
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    January 11, 2011
    Report Date
    August 25, 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

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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 4. REFERENCE MFR REPORTS: # 1627487-2014-06254, 1627487-2014-06255, 1627487-2014-06256. THE PT HAD TWO 3186 LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT ALLEGES SHE EXPERIENCED PAINFUL BURNING SENSATIONS WHILE CHARGING, AND SHOCKING SENSATIONS. THE PT STATED THE ISSUES WERE RESOLVED WITH A LEAD REPLACEMENT. THE PT'S ENTIRE SCS SYSTEM WAS REMOVED ON (B)(6) 2014. ADDITIONAL INFO IS NEEDED TO CLARIFY THE NATURE OF THE PT'S ISSUES. SJM WAS MADE AWARE OF THE ISSUES ON (B)(6) 2014, AND THE PT'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 PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. 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 4. REFERENCE MFR REPORT: 1627487-2014-06254. REFERENCE MFR REPORT: 1627487-2014-06255. REFERENCE MFR REPORT: 1627487-2014-06256. A REVIEW OF THE PATIENT'S MEDICAL RECORD WAS PERFORMED AND NOTED THE FOLLOWING ISSUES. ON (B)(6) 2014, THE PATIENT'S IPG WAS REPLACED WITH A COMPETITOR'S IPG USING THE EXISTING SJM LEADS. ON (B)(6) 2014, THE PATIENT'S SJM LEADS WERE REMOVED AND REPLACED WITH COMPETITOR'S LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522481 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 48915

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other