BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3960962 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-20065
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION
    Product Code
    GZB
    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

    THE PATIENT HAS 2 SCS LEADS WITH THE SAME LOT NUMBER BUT DIFFERENT SERIAL NUMBERS. DEVICE 1 OF 2 REFERENCE MFR. REPORT #1627487-2014-20066. IT WAS REPORTED THE PATIENT EXPERIENCED KNEE PAIN, LEG NUMBNESS AND LOSS OF LEG MOBILITY IN THE RIGHT LEG FOLLOWING HER PERMANENT PROCEDURE. THE PHYSICIAN DETERMINED A LUMBER NEUROPRAXIA INJURY AND PERFORMED A BLOOD PATCH. FOLLOW UP IDENTIFIED THE ISSUED HAVE RESOLVED AND THE PATIENT IS RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429087 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL -NEUROMODULATION 3186 4600198

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR SCS IPG, MODEL: 3789| IMPLANT DATE:| SCS ANCHOR, MODEL: 1192 (2)| IMPLANT DATE: