BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3223195 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-06590
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMDULATION
    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 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2013-06591. REFERENCE MFR REPORT: 1627487-2013-06592. IT WAS REPORTED THE PATIENT STOPPED USING HER SCS SYSTEM BECAUSE IT WAS CAUSING HER PAIN IN HER LEGS. THE PATIENT STATED SHE WAS IMPLANTED FOR BACK PAIN, AND SHE WOULD HAVE TO TURN HER AMPLITUDE REALLY HIGH TO OBTAIN ANY RELIEF. CONSEQUENTLY, THE HIGH AMPLITUDE WOULD CAUSE PAIN IN HER LEGS. THE PATIENT DOES NOT RECALL HOW LONG IT HAS BEEN SINCE SHE LAST USED HER SYSTEM. IT IS UNDETERMINED WHETHER HER SCS IPG IS STILL FUNCTIONAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314604 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMDULATION 3186 2819703

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (X2)