BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTROD

    MDR report key: 3012171 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-15353
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED WHEN THE PATIENT'S TRIAL LEAD WAS IMPLANTED, HE ONLY FELT RIB STIMULATION. THE PHYSICIAN MOVED THE TRIAL LEAD, HOWEVER THE LEAD WENT ANTERIOR CAUSING THE PATIENT DISCOMFORT. THE PATIENT ELECTED TO END THE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106500 OCTROD SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention