BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3052241 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-01389
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 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 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 HAS TWO OCCIPITAL (OFF-LABEL USE) LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS EXPERIENCING UNINTENDED STIMULATION. SHE UNDERWENT REVISION SURGERY ON (B)(6) 2013, TO REPOSITION HER LEADS DUE TO MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137588 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3189 3874015

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192