BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3226529 · Received July 8, 2013

    Report

    Report Number
    1627487-2013-12882
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    December 1, 2012
    Report Date
    June 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 3 OF 3. REFERENCE MFR REPORT NUMBER 1627487-2013-12880, 1627487-2013-012881.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308809 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3189 3622343

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other SCS ANCHORS: MODEL 1192| IMPLANT:| IMPLANT:| SCS ANCHORS: MODEL 1192