BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2921922 · Received January 4, 2013

    Report

    Report Number
    1627487-2013-15035
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    March 1, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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

    THE PT HAD TWO LEADS IMPLANTED FROM THE SAME LOT NUMBER. THE PT REPORTED, HE HAS NOT RECEIVED ADEQUATE STIMULATION IN HIS RIGHT LEG SINCE HIS SYSTEM WAS IMPLANTED. THE PT INDICATES, HE DOES HAVE ADEQUATE STIMULATION IN HIS LEFT LEG, HOWEVER, HE FEELS A SHOCKING SENSATION IN HIS LEFT LEG WHEN WALKING, LAYING DOWN, AND WHEN APPLYING PRESSURE TO HIS LEAD SITE. THE PT ALSO STATED HE HAS BEEN REPROGRAMMED NUMEROUS TIMES, BUT THE ISSUE HAS NOT BEEN RESOLVED. PT CLAIMS TO ALSO SUFFER FROM MIGRAINES SINCE BEING IMPLANTED. THE PT INDICATED THAT HIS PHYSICIAN WAS GOING TO TAKE SURGICAL INTERVENTION AT A LATER DATE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5488 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3523862

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788