BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2980076 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-04225
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    DEVICE 2 OF 3. REFERENCE MFR REPORT: 1627487-2013-04224, 04226. THE PT REC'D TWO LEADS WITH DIFFERENT LOT NUMBERS. ALL POSSIBLE LOTS WILL BE REPORTED. IT WAS REPORTED THE PT'S LUMBAR SCS SYSTEM WAS TO BE EXPLANTED. THE PHYSICIAN PLANNED TO PERFORM A FUSION SURGERY, WHICH IS TO ADDRESS THE LOWER BODY PAIN. THERE HAD BEEN NO REPORTED LOSS OF STIMULATION FROM THE LUMBAR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77429 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2745545

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192