BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3926143 · Received June 13, 2014

    Report

    Report Number
    1627487-2014-02420
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    February 7, 2013
    Report Date
    May 21, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-02421. THE PATIENT RECEIVED TWO SCS LEADS FORM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT EXPERIENCED A FALL AND HIS SCS STIMULATION CHANGED SINCE THEN. A SJM REPRESENTATIVE MET WITH THE PATIENT, HOWEVER, EFFECTIVE STIMULATION COULD NOT BE ACHIEVED BY REPROGRAMMING. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014, IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014. IT WAS DISCOVERED THE PATIENT'S SCS IPG WAS INOPERABLE BECAUSE THE PATIENT STOPPED CHARGING HIS IPG MONTHS AGO. THE PATIENT'S ENTIRE SCS SYSTEM WAS REMOVED. THE PHYSICIAN DECIDED TO RE-TRIAL THE PATIENT WITH A DIFFERENT MODEL LEAD. THE TRIAL WAS SUCCESSFULLY COMPLETED ON (B)(6) 2014. A NEW IPG WAS IMPLANTED. THE PATIENT REPORTED RECEIVING EFFECTIVE STIMULATION POSTOPERATIVE. ALL REPORTED ISSUES HAVE BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349118 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3463280

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other IMPLANT:| SCS ANCHOR: MODEL 1192 (X2)