BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3052900 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-15437
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 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 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-15436. IT WAS REPORTED THE PT'S STIMULATION HAD DIMINISHED AND SHE EVENTUALLY WAS UNABLE TO FEEL STIMULATION. THE PT WAS REPROGRAMMED AND PT IS RECEIVING STIMULATION IN HER STOMACH. X-RAYS WERE TAKEN AND INDICATED NO LEAD MIGRATION. THE PT IS TO MEET WITH THE SJM REPRESENTATIVE AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135055 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3190279

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)