BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2971047 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-15201
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 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

    DEVICE 3 OF 3. REFERENCE MFR REPORT: 1627487-2013-15199, 1627487-2013-15200. THE PATIENT HAS TWO LEADS (FROM DIFFERENT LOTS) IMPLANTED AS PART OF HIS SCS SYSTEM. IT WAS REPORTED, THE PATIENT HAS PAIN AT THE IPG SITE WHEN LYING ON HIS BACK. THE PATIENT INDICATES STIMULATION IS INEFFECTIVE. THE PATIENT HAS REQUESTED SURGICAL INTERVENTION BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69834 OCTRODE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3203819

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention IMPLANT:| SCS ANCHOR: MODEL 1192 (2)