BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3141562 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-15694
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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

    IT WAS REPORTED DURING A SURGICAL PROCEDURE TO IMPLANT A SECOND LEAD FOR RIGHT SIDE STIMULATION, THE PT STATED SHE WAS IN PAIN AND REQUESTED HER PHYSICIAN END THE PROCEDURE. THE PHYSICIAN ABANDONED THE IMPLANT PROCEDURE. THE PT ALSO REQUESTED TO HAVE HER SCS SYSTEM EXPLANTED. THREE DAYS AFTER THE ABANDONED PROCEDURE, THE PT STATED HER RIGHT LEG WAS NUMB. THE PHYSICIAN INSTRUCTED THE PT TO GO TO THE ER WHICH THE PT DID. THE PT STATED SHE WAS RELEASED FROM THE ER THE SAME DAY BUT DID NOT PROVIDE WHAT TREATMENT WAS GIVEN. PT STATES RIGHT LEG NUMBNESS HAS LESSENED. ALTHOUGH, PT STATES SHE DOES WANT HER SCS SYSTEM, SHE PLANS TO PURSUE SURGICAL INTERVENTION TO IMPLANT A SECOND LEAD FOR RIGHT SIDE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232304 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SCS LEAD: MODEL 3186| SCS ANCHOR: MODEL 1192| SCS IPG: MODEL 3788| IMPLANTED:| IMPLANTED:| IMPLANTED: