BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3223023 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-04864
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 17, 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 UNABLE TO INCREASE THE AMPLITUDE OF THE STIMULATION. THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING, BUT FOLLOW UP INDICATED THE PATIENT MAY HAVE HAD A FRACTURED LEAD BECAUSE ALL IMPEDANCES WERE INVALID ON THE LEAD. THE PHYSICIAN OPTED TO REPLACE THE LEAD. FOLLOW UP IDENTIFIED THE PATIENT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315485 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3612479

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other IMPLANT:| IMPLANT:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192| SCS LEAD: MODEL 3163| IMPLANT: