BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4173838 · Received October 10, 2014

    Report

    Report Number
    1627487-2014-24270
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 18, 2014
    Report Date
    September 18, 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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED 2 LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT LOST STIMULATION. X-RAYS INDICATED THE LEADS HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE PT'S SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643105 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3189 118563

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other IMPLANT DATE:| SCS IPG: MODEL 3716