BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2980022 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-01197
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ST. JUDE MED - NEUROMDOULATION
    Product Code
    LGW
    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-1198. IT WAS REPORTED THE PT EXPERIENCED RIGHT FOOT/HEEL PAIN POSTOPERATIVELY. SHE STATED IT WAS A VERY SHARP "SHOCKING" SENSATION AT INTERVALS. STIMULATION WAS UNABLE TO RESOLVE THE ISSUE. THE PHYSICIAN PULLED THE LEADS DOWN, BUT THE STABBING PAIN DID NOT SUBSIDE. THE PHYSICIAN REMOVED BOTH LEADS. THE DISCOMFORT IMPROVED AFTER THE LEADS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77717 OCTRODE SCS LEAD LGW ST. JUDE MED - NEUROMDOULATION 3086 3886806

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention