BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3133689 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-04622
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 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 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 LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT HAD INEFFECTIVE STIMULATION AND WAS ALSO RECEIVING UNWANTED STIMULATION IN THE ABDOMEN. X-RAYS WERE TAKEN WHICH REVEALED ONE LEAD HAD MOVED PROXIMALLY 2 VERTEBRAL SEGMENTS. IT WAS REPORTED THE PHYSICIAN PLANNED TO UNDERTAKE SURGICAL INTERVENTION TO ADDRESS THE ISSUE AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223214 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL, NEUROMODULATION 3186 3787864

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: