BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3925753 · Received June 13, 2014

    Report

    Report Number
    1627487-2014-02427
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    February 24, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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

    THE PT RECEIVED TWO PNS (OFF-LABEL) LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT COMPLAINED HER STIMULATION WAS NOT WORKING WELL, AND SHE DOES NOT HAVE ANY PAIN RELIEF. A SJM REP MET WITH THE PT. A DIAGNOSTICS OF THE PT'S SYSTEM DID NOT SHOW ANY ANOMALIES. THE PT HAS PERIPHERAL (OFF-LABEL) PLACEMENT LEADS, AND THE PHYSICIAN ASSISTANT PRESENT DURING THE MEETING PRESSED DOWN ON THE LEADS TO SEE IF THE LEADS MIGHT BE TOO DEEP BUT THE ISSUE PERSISTED. X-RAYS HAVE BEEN ORDERED. FURTHER EVAL OF THE ISSUE IS PENDING THE X-RAYS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350675 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3956558

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR SCS IPG: MODEL 3788| IMPLANT DATE: