BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4112616 · Received September 10, 2014

    Report

    Report Number
    1627487-2014-26731
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 20, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    THE PATIENT REPORTS THAT HE IS NOT RECEIVING EFFECTIVE STIMULATION EVEN AT MAXIMUM AMPLITUDE. THE PATIENT REPORTS HE FELL APPROXIMATELY 8 MONTHS AGO, HOWEVER; THIS ISSUE RECENTLY OCCURRED. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PATIENT WAS ADVISED TO FOLLOW UP WITH HIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559888 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 A12754

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS IPG: MODEL 3608