BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3133221 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-03668
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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.

    Description of Event or Problem · 1

    DEVICE 4 OF 4. REFERENCE MFR. REPORTS: 1627487-2013-03665, 03666 AND 03667. THE PATIENT REPORTED HE EXPERIENCED HEATING AT HIS SCS IPG POCKET SITE WHILE CHARGING AND SUBSEQUENTLY STOPPED CHARGING APPROXIMATELY 3 MONTHS AGO. THE PATIENT ALSO REPORTED HE IS EXPERIENCING PAIN AND WOULD LIKE TO HAVE HIS SCS SYSTEM EXPLANTED. MOREOVER, THE PATIENT REPORTED THE SCS SYSTEM AGGRAVATES HIS SYMPTOMS AND HE IS GENERALLY UNHAPPY WITH IT. ADDITIONALLY, THE PATIENT REPORTED HE DOES NOT LIKE HIS SCS SYSTEM SETTINGS AND STATED "EVERYTHING" WHEN ASKED IF HE HAS ANY OTHER ISSUES WITH THE SYSTEM. A REPLACEMENT CHARGING SYSTEM (LOW ENERGY) WAS SENT TO THE PATIENT TO ADDRESS THE POCKET HEATING ISSUE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223090 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3794702

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention