BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3141575 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-13799
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 3. REFERENCE MFR REPORT: 1627487-2013-13798 AND 1627487-2013-13800. IT WAS REPORTED THE PT COULD NOT COMMUNICATE WITH HIS IPG USING EXTERNAL DEVICES. THE PT STATED HE HAS NOT CHARGED HIS IPG FOR OVER 3 MONTHS BECAUSE HE WASN'T RECEIVING EFFECTIVE STIMULATION. THE PT ALSO STATED THE STIMULATION WOULD CHANGE WHEN HE MOVED HIS NECK, HE WOULD FEEL "A SHOCKING SENSATION" IN HIS NECK OR OVERSTIMULATION IN HIS BACK. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232224 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2816050

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANTED:| SCS ANCHOR: MODEL 1192 (2)