BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3032526 · Received April 1, 2013

    Report

    Report Number
    1627487-2013-13487
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ST JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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: 1627487-2013-13488. THE PATIENT HAS TWO LEADS FROM DIFFERENT LOT NUMBERS, REPORTING ON BOTH. IT WAS REPORTED THE PATIENT¿S STIMULATION HAD NAUSEATED HER AND WAS NOT ADDRESSING HER PAIN. FOLLOW-UP INFO IDENTIFIED THE PATIENT WAS STILL FEELING NAUSEOUS WHEN THE STIMULATION IS ON. SHE ALSO STATED HER PAIN IS WORSE SINCE SHE WAS IMPLANTED WITH THE SCS SYSTEM. THE PATIENT WANTS TO HAVE HER SYSTEM EXPLANTED FOLLOW-UP PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132210 OCTRODE SCS LEAD LGW ST JUDE MEDICAL NEUROMODULATION 3186 3800318

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: