BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-8

    MDR report key: 2881333 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-02839
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    October 21, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 2. REF MFR REPORT: 1627487-2012-02838. IT WAS REPORTED THE PT BEGAN EXPERIENCING A HIGH-FREQUENCY "BURNING" SENSATION DOWN HIS LEGS. HE STATED THAT SINCE THE SENSATION BEGAN IT FEELS LIKE HIS STIMULATION DOES NOT TURN OFF. HE STATED HE STILL FEELS THE SENSATION IN HIS FEET WITH STIMULATION OFF AND A PHYSICIAN TOLD HIM NOTHING WAS WRONG WITH HIS FEET. IT WAS REPORTED THE PT WILL MEET WITH THE SJM REP FOR REPROGRAMMING. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-8 SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3286 3456514

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)