BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3052291 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-01395
    Event Type
    Injury
    Date Received
    April 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-1394. IT WAS REPORTED THE PT'S IPG SITE WAS UNCOMFORTABLE AND WOULD GET WARM AT TIMES. IT WAS ALSO REPORTED THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION AND EXPERIENCED UNCOMFORTABLE STIMULATION. HER ENTIRE SCS SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139353 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3602053

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention