BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 7643181 · Received June 27, 2018

    Report

    Report Number
    3006705815-2018-01492
    Event Type
    Injury
    Date Received
    June 27, 2018
    Report Date
    July 23, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    GZB
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. 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. MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REFERENCE MFR. REPORT# 1627487-2018-06026. REFERENCE MFR. REPORT# 3006705815-2018-01491. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REFERENCE MFR. REPORT# 1627487-2018-06026. REFERENCE MFR. REPORT# 3006705815-2018-01491. IT WAS REPORTED THE PATIENT EXPERIENCED A POSSIBLE INFECTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, HOWEVER THE CULTURES PRESUMED NEGATIVE FOR AN INFECTION. IN TURN, THE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484793 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000033837 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization