BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3121891 · Received May 15, 2013

    Report

    Report Number
    1627487-2013-05685
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    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 TWO LEADS (FROM THE SAME LOT). IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH CERVICAL MYELOPATHY. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2013. DURING THE PROCEDURE, THE DOCTOR REMOVED THE LEADS FROM THE EPIDURAL SPACE AND ANCHORED THEM IN ANOTHER LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214322 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3189 3778266

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANT:| SCS ANCHORS, MODEL: 1192 (X2)| IMPLANT:| SCS IPG: MODEL 3788