BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4202567 · Received October 22, 2014

    Report

    Report Number
    1627487-2014-26877
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    March 28, 2014
    Report Date
    October 1, 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 IS IMPLANTED WITH A SCS SYSTEM THAT INCLUDES TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT HAS NOT RECEIVED EFFECTIVE STIMULATION AND IS EXPERIENCING CRAMPS AND PAIN IN HER ABDOMEN WITH THE STIMULATION ON, HOWEVER, WHEN THE STIMULATION IS TURNED OFF THE CRAMPING SUBSIDES. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUES. X-RAYS ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673904 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 444518

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)