BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3961310 · Received July 18, 2014

    Report

    Report Number
    1627487-2014-03484
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 23, 2014
    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.

    Description of Event or Problem · 1

    DEVICE 2 OF 3 - REFERENCE MFR REPORTS: 1627487-2014-03483 AND 1627487-2014-03485. THE PATIENT HAS 2 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT EXPERIENCED HEATING WHILE CHARGING, INCREASED RECHARGE BURDEN, OVERSTIMULATION, BURNING PAIN AT THE LEAD SITES AND IPG COMMUNICATION ISSUES. THE PATIENT IS CONSULTING WITH THE PHYSICIAN REGARDING SURGICAL INTERVENTION. THE MANUFACTURER'S RECORDS INDICATE THE PATIENT RECEIVED A LOW ENERGY CHARGING SYSTEM. ON 08/01/2012, ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT A FIELD ACTION LETTER 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. 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
    421150 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3610038

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192(2)