BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012209 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-12337
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 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 INFORMATION 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

    IT WAS REPORTED THE PT LOST STIMULATION COVERAGE. X-RAYS REVEALED THE LEADS MIGRATED. THE PHYSICIAN REPOSITIONED THE LEADS AND EFFECTIVE STIMULATION WAS REGAINED. NOTE THE PT RECEIVED TWO LEADS FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104571 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3851114

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHORS: MODEL 1192(2)