BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3052390 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-06136
    Event Type
    Injury
    Date Received
    April 3, 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
    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

    IT WAS REPORTED, THE PATIENT LOST EFFECTIVE STIMULATION COVERAGE. X-RAYS TAKEN INDICATED THE LEAD HAD MIGRATED. THE PATIENT WAS SCHEDULED FOR A LEAD REVISION, HOWEVER DURING THE REVISION PROCEDURE THE PHYSICIAN DECIDED TO REPLACED THE LEAD. EFFECTIVE STIMULATION COVERAGE WAS CAPTURED POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135637 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3820134

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: