BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3954872 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-25518
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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

    THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY (B)(4). IT WAS REPORTED THE PATIENT (B)(6) BEGAN EXPERIENCING PAINFUL STIMULATION IN (B)(6) 2014. IN TURN, THE PATIENT'S STIMULATION WAS TURNED OFF. AN SJM REPRESENTATIVE MET WITH THE PATIENT AT A LATER DATE FOR REPROGRAMMING AND WAS UNABLE TO PROVIDE RESOLUTION. AS A RESULT, THE PATIENT WAS ADMINISTERED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415882 UNKNOWN SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other IMPLANT DATE:| SCS IPG: MODEL 3788