BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 8951047 · Received August 30, 2019

    Report

    Report Number
    3006705815-2019-03346
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    August 22, 2019
    Report Date
    September 11, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    (REFERENCE REG NUMBER: 3006705815-2019-09916). IT WAS REPORTED DURING THE IPG REPLACEMENT PROCEDURE (REFERENCE REG NUMBER:1627487-2019-09917), THE DOCTOR OPENED THE LEAD INCISION SITE TO POTENTIALLY RE-POSITION ONE LEAD THAT HAD MIGRATED ONE LEVEL DOWN, BUT DECIDED TO LEAVE IT AS IT WAS. IN TURN, STIMULATION WAS SUCCESSFULLY TURNED BACK ON AFTER. AS A RESULT, EFFECTIVE THERAPY WAS RESTORED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743634 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000039945 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3186, SCS LEAD