BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4091816 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-03557
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 9, 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 INFO 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. IT WAS REPORTED THE PATIENT WA RECEIVING UNINTENDED CHEST WALL STIMULATION AND AS A RESULT HAS STOPPED USING STIMULATION. PER THE RADIOLOGIST, X-RAYS REVEALED ONE OF THE SCS LEADS HAS MIGRATED. THE PATIENT IS TO CONSULT WITH THE PHYSICIAN REGARDING SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526187 OCTRODE SCS LEAD, GZB GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4640020

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other IMPLANT DATE:| SCS IPG, MODEL: 3789