BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3961346 · Received July 18, 2014

    Report

    Report Number
    1627487-2014-25522
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ST JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REF MFR REPORT #: 1627487-2014-25521. IT WAS REPORTED THE PATIENT ((B)(6)) STOPPED RECEIVING STIMULATION DUE TO INVALID IMPEDANCES. IN TURN, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421216 OCTRODE SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3189 4151422

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANT:| SCS EXTENSION, MODEL: 3383