BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2932149 · Received January 25, 2013

    Report

    Report Number
    1627487-2013-01100
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 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 1 OF 2. REF MFR REPORT #: 1627487-2013-1101. THE PT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION FROM HER SCS SYSTEM IMPLANTED FOR PNFS (PERIPHERAL NERVE FIELD STIMULATION), (OFF LABEL USE). IT WAS ALSO REPORTED THE PT IS EXPERIENCING A FREQUENT RECHARGE BURDEN WITH HER IPG. AN SJM REP MET WITH THE PT AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PT IS CONSIDERING HAVING HER SCS SYSTEM REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36218 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3536674

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention