BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3851337 · Received May 22, 2014

    Report

    Report Number
    1627487-2014-21321
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 RECEIVED A TRIAL IMPLANT ON (B)(6), 2014. IT WAS REPORTED THE PATIENT WAS RECEIVING INAPPROPRIATE CHEST AND ABDOMINAL STIMULATION. PER THE PATIENT, THE LEADS HAD MOVED AND THE PHYSICIAN MANIPULATED THE LEAD ON (B)(6), 2014. SUBSEQUENTLY, THE PATIENT WAS REPROGRAMMED AND THE SJM REPRESENTATIVE WAS ABLE TO RESTORE EFFECTIVE COVERAGE. HOWEVER, ON (B)(6), 2014, THE PATIENT FELT INAPPROPRIATE STOMACH STIMULATION. THE PATIENT'S TRIAL WAS TO END ON (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306174 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other