BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 7198419 · Received January 16, 2018

    Report

    Report Number
    3006705815-2018-00120
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    December 19, 2017
    Report Date
    January 16, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS LIMITED INFORMATION 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 5: REFERENCE MFR REPORT: 3006705815-2018-000121, 1627487-2018-00581, 1627487-2018-00582 AND 1627487-2018-00583. IT WAS REPORTED THE PATIENT WENT TO THE ER FOLLOWING HIS SCS SYSTEM IMPLANT PROCEDURE DUE TO A POSSIBLE HEMATOMA. THE PATIENT WENT INTO THE EMERGENCY ROOM WITH SIGNIFICANT LEG WEAKNESS. THE CONCERN WAS AN EPIDURAL HEMATOMA. AN MRI CAME BACK AND IT WAS NEGATIVE FOR AN EPIDURAL HEMATOMA. THE ER PHYSICIANS DETERMINED THE PATIENT HAS SOME TYPE OF SYSTEMIC ILLNESS UNRELATED TO THE STIMULATOR OR PROCEDURE. THE PATIENT WAS KEPT FOR MONITORING FOR A FEW MORE DAYS. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41822 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000047637

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| O