BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3032298 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-00196
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 3 OF 3. REFERENCE MFR REPORT #S 1627487-2013-00194 AND 1627487-2013-00195. IT WAS REPORTED THE PATIENT'S (AUSTRALIA) SCS SYSTEM WAS EXPLANTED. ALTHOUGH THE DEVICES WERE FUNCTIONING AND COVERING THE PATIENT'S PAIN AREA, THE RESULTING STIMULATION REPORTEDLY GENERATED A NEW SENSATION IN ADDITION TO HIS EXISTING PAIN. THE PATIENT HAD PREVIOUSLY UNDERGONE REPROGRAMMING IN AN EFFORT TO OBTAIN EFFECTIVE RELIEF, BUT LATER DECIDED TO HAVE THE SYSTEM REMOVED. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131211 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3333070

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention