BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3231526 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-06606
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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. REF MFR REPORT: 1627487-2013-06605. THE PT WAS IMPLANTED WITH TWO LEAD FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS SCHEDULED TO HAVE HIS SCS SYSTEM REMOVED BECAUSE HE DID NOT RECEIVE ANY PAIN RELIEF. IT WAS ALSO REPORTED THE PT EXPERIENCED DISCOMFORT AT HIS IPG SITE WHEN SITTING DOWN. F/U IDENTIFIED THE PT'S SCS SYSTEM WAS REMOVED ON (B)(6) 2013. NO PRODUCT WILL BE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323700 OCTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3186 3290634

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other SCS ANCHOR: MODEL 1192 (X2)| IMPLANT DATE: