BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2850099 · Received November 26, 2012

    Report

    Report Number
    1627487-2012-11705
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    June 21, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 2. REFERENCE MFR REPORT: 1627487-2012-11706. THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION FROM THE SYSTEM. IT WAS REPORTED, THE SYSTEM WAS FUNCTIONAL, HOWEVER, THE RELIEF WAS INSUFFICIENT FOR THE PATIENT. THE PHYSICIAN OPTED TO EXPLANT THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3153759

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: