BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2970985 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-03231
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    May 15, 2012
    Report Date
    January 23, 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

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-03230. IT WAS REPORTED THE PATIENT HAS BEEN EXPERIENCING PAIN AT HER SCS IPG POCKET SITE SINCE IMPLANT. IT WAS ALSO REPORTED THE PATIENT EXPERIENCES SCS IPG POCKET STIMULATION WHILE USING SYSTEM STIMULATION. ADDITIONALLY, LEAD DIAGNOSTICS SHOWED LOW IMPEDANCE VALUES FOR THE SCS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69444 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3376646

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192