BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2890925 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-14249
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 3, 2012
    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

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. 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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT HAD TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THAT THE PT COMPLAINED OF PAIN IN HER RIBS ON THE LEFT SIDE AND A HEADACHE. IT WAS ALSO REPORTED THERE WAS PURULENT DRAINAGE AT THE LEAD ENTRY SITE WHEN THE PHYSICIAN REMOVED THE DRESSING. PRIOR TO TRIAL LEAD REMOVAL, X-RAY SHOWED THE LEADS HAD MIGRATED. THE PT WAS SATISFIED WITH THE STIMULATION DURING THE TRIAL AND PLANS TO PROCEED WITH THE PERMANENT SCS SYS. POST TRIAL LEAD PULL OUT, THE PT CONTINUES TO HAVE PAIN AT THE LEAD ENTRY SITE AND A HEADACHE. THE PT WAS TREATED WITH ANTIBIOTICS AND PLANS TO F/U WITH HER NEUROSURGEON AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3824586

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention