BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1962793 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-02036
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 3. REFERENCE MANUFACTURER REPORTS: 1627487-2011-02034 AND 1627487-2011-02037. THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS. IT WAS REPORTED THE IPG WAS EXPLANTED AND REPLACED DUE TO PERSISTENT PAIN AT THE IPG POCKET. AS THE PHYSICIAN SUSPECTED, IT WAS DUE TO THE SIZE OF THE ORIGINAL IPG, A SMALLER MODEL WAS IMPLANTED. DURING THE IPG REVISION, THE PHYSICIAN NOTED THE PT'S LEAD HAD MIGRATED. AS THE PT WAS RECEIVING ADEQUATE COVERAGE, THE PHYSICIAN OPTED NOT TO REPOSITION THE LEAD. AS THE LOT NUMBER OF THE LEAD REFERENCED IN THE REPORT WAS NOT PROVIDED, A REPORT HAS BEEN SUBMITTED FOR BOTH LEADS. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 69360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention