BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4091838 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-05616
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 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

    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 2 OF 2. REFERENCE MFR REPORT # 1627487-2014-05615. ON (B)(6) 2014, THE PT UNDERWENT A TRIAL PROCEDURE. DURING THE PROCEDURE, THE PT EXPERIENCED CEREBROSPINAL FLUID LEAKAGE. AS A RESULT, THE PT WAS KEPT IN THE HOSPITAL OVERNIGHT. ON (B)(6) 2014, THE PT BEGAN TO EXPERIENCE A HEADACHE AND DISCOMFORT AT THE BOTH LEAD SITES. AS A RESULT, THE LEADS WERE REMOVED ON (B)(6) 2014. A BLOOD PATCH WAS PERFORMED ON (B)(6) 2014, ON (B)(6) 2014, THE PT WAS READMITTED TO THE HOSPITAL AND ANOTHER BLOOD PATCH WAS PERFORMED. THE HEADACHE THE PT HAD BEEN EXPERIENCING RESOLVED THE FOLLOWING DAY. THE PT'S CEREBROSPINAL FLUID WAS TESTED AND THE RESULTS CAME BACK NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526146 OCTRODE SCS LEADS GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4592318

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization