BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3182382 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-04772
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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

    THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT WAS REPROGRAMMED BUT WAS RECEIVING INADEQUATE STIMULATION. THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR ADDITIONAL REPROGRAMMING BUT WAS UNABLE TO PROVIDE STIMULATION TO HIS FEET. THE PATIENT STATED THE STIMULATION FELT MORE EFFECTIVE, HOWEVER, HE WAS EXPERIENCING SOME ABDOMINAL STIMULATION. THE PATIENT WAS TO USE THE PROGRAMS AND REPORT THE EFFICACY AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271169 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3816521

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR IMPLANT:| SCS ANCHOR: MODEL 1192 (2)| SCS IPG: MODEL 3788| IMPLANT: