BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4091976 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-06250
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    August 1, 2014
    Report Date
    June 9, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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

    DEVICE 1 OF 3. REFERENCE MFR REPORTS: # 1627487-2014-06251, 1627487-2014-06252. THE PT HAS TWO LEADS WITH THE SAME LOT NUMBER AND TWO ANCHORS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION. THE PT IS EXPERIENCING AUTO-REDUCING WITH CONTACTS 9-16. X-RAYS INDICATE THE LEAD HAS PULLED OUT OF THE IPG HEADER AND THE LEFT LEAD HAS MIGRATED. IT WAS ALSO REPORTED THE PT IS EXPERIENCING PAIN AT THE ANCHOR SITE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522482 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3263350

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other