BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3960642 · Received July 21, 2014

    Report

    Report Number
    1627487-2014-01472
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    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

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 1 OF 3. REF MFR REPORTS: 1627487-2014-01473, 01474. IT WAS REPORTED THE PT IS WITHOUT LEFT SIDE STIMULATION. THE PAIN PATTERN IS BILATERAL BACK AND LEGS. AFTER FURTHER INVESTIGATION, IT WAS REVEALED THE LEAD HAS MIGRATED FROM T8 TO T11. NO KNOWN TRAUMATIC EVENTS HAVE OCCURRED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 IN EFFORTS TO REVISE THE LEADS. DURING PROCEDURE, THE PHYSICIAN NOTED PURULENT DRAINAGE AND PUSS EXTENDING FROM THE LEAD AND IPG SITES. SUBSEQUENTLY, THE PHYSICIAN OPTED TO EXPLANT THE SCS SYSTEM. CULTURE WERE TAKEN, HOWEVER, RESULTS ARE UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424001 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4358121

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other