BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2973538 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-02254
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 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

    RESULT - THE COMPLAINT FOR CANNOT IMPLANT PRODUCT CANNOT BE CONFIRMED THROUGH PRODUCT TESTING ALONE. AS RECEIVED, THE RETURNED LEAD WAS IN GOOD CONDITION. MICROSCOPIC INSPECTION DID NOT REVEAL ANY ANOMALIES WHICH WOULD HAVE CONTRIBUTED TO THE COMPLAINT. PER THE EVENT DETAILS, THE RETURNED LEAD COULD NOT BE IMPLANTED DUE TO SCAR TISSUE AND BONY FUSIONS. 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

    THE PT UNDERWENT A PROCEDURE TO RECEIVE A TRIAL SCS SYSTEM. IT WAS REPORTED, THE PHYSICIAN COULD NOT ADVANCE THE LEAD DUE TO SCAR TISSUE AND BONY FUSIONS. THE TRIAL PROCEDURE WAS CONSEQUENTLY ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72573 OCTRODE SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3086 3859852

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention