BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012233 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-00161
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PATIENT'S ((B)(6)) LEAD DUE TO RETROAURICULAR PAIN AT THE TIPS OF THE DEVICE (OFF-LABEL). THE DISCOMFORT WAS SAID TO BE MORE ACUTE WHEN STIMULATION WAS IN USE. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. EFFECTIVE STIMULATION WAS CAPTURED FOR THE PATIENT FOLLOWING THE PROCEDURE. THE PATIENT'S STATUS WITH RESPECT TO THE PAIN HAS NOT BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104535 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3799314

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: