BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3032314 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-00197
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THIS LEAD WAS INTENDED FOR IMPLANT IN THE PATIENT'S (B)(6) SUBOCCIPITAL REGION (OFF LABEL). DURING THE PLACEMENT OF THE DEVICE, THE PHYSICIAN NOTED THE LEAD HAD PENETRATED THROUGH THE PATIENT'S SKIN. THE DEVICE WAS REMOVED, AND A NEW LEAD WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130656 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3782271

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention