BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4172683 · Received October 10, 2014

    Report

    Report Number
    1627487-2014-23678
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 4. REFERENCE MFR REPORT: 1627487-2014-23677, 23679, 23680. IT WAS REPORTED, THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION COVERAGE FROM HER SCS SYSTEM. THEREFORE, THE PT STOPPED CHARGING HER SYSTEM. AS A RESULT, THE PT'S IPG BECAME INOPERABLE. SUBSEQUENTLY, THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014, WHERE HER IPG AND LEADS WERE REMOVED AND REPLACED. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643294 OCTRODE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3736585

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1192