BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3031925 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-06114
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 WAS NOT GETTING ADEQUATE STIMULATION. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND PERFORMED AN IMPEDANCE CHECK AND FOUND ONE HALF OF THE CONTACTS TO BE INVALID. SURGICAL INTERVENTION WAS UNDERTAKEN AND A NEW LEAD WAS IMPLANTED. EFFECTIVE STIMULATION COVERAGE WAS CAPTURED, POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128463 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2881610

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (X2)| SCS IPG: MODEL 3788