BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110734 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-15621
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 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

    EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-15620. IT WAS REPORTED THE PT WOKE UP AND HAD LOST MOVEMENT ON HER LEFT SIDE AND WAS UNABLE TO MOVE HER LEFT LEG 3 DAYS AFTER HAVING A TRIAL SYSTEM IMPLANTED. THE PT'S PHYSICIAN INDICATED PT APPEARED TO HAVE STROKE LIKE SYMPTOMS AND WAS ADMITTED TO THE HOSPITAL. A STROKE WAS LATER RULED OUT. THE PT WAS ALSO THOUGHT TO HAVE A POSSIBLE INFECTION WHICH WAS LATER SUSPECTED TO HAVE CAUSED SPINAL CORD INFLAMMATION. THE TRIAL LEADS WERE EXPLANTED AND AN MRI WAS TAKEN BUT RESULTS WERE INCONCLUSIVE. FOLLOW-UP INFO INDICATED NEITHER A SPINAL CORD OR LEAD SITE INFECTION WERE CONFIRMED, ONLY SUPERFICIAL SKIN IRRITATION. NO DIAGNOSIS HAS BEEN CONFIRMED AND THE PHYSICIAN IS TREATING THE PT WITH IV ANTIBIOTICS. THE PT HAS REGAINED MOVEMENT OF HER UPPER EXTREMITIES BUT IS STILL UNABLE TO MOVE HER LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204790 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 3904342

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R