BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 5443864 · Received February 18, 2016

    Report

    Report Number
    1627487-2016-00753
    Event Type
    Injury
    Date Received
    February 18, 2016
    Report Date
    January 27, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

    DEVICE 1 OF 2.REFERENCE MFR. REPORT:1627487-2016-000754.IT WAS REPORTED THE PATIENT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION AS STIMULATION WAS PRIMARILY IN THE STOMACH AREA (DATE OF EVENT IS UNKNOWN). X-RAYS REVEALED THE SCS LEADS HAD MIGRATED. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2016 DURING WHICH THE LEADS WERE REPOSITIONED WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100809 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 5215042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 1192, SCS ANCHOR