BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3223314 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-08323
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    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

    THE PATIENT RECEIVED TWO TRIAL LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT DEVELOPED PAIN AND TINGLING SENSATION IN HER LEGS AFTER THE TRIAL PROCEDURE; HENCE, THE LEADS WERE EXPLANTED ON THE SAME DAY. FOLLOW-UP IDENTIFIED THE PATIENT'S SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317635 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4021026

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other