BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3931868 · Received June 20, 2014

    Report

    Report Number
    1627487-2014-26519
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 30, 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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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

    THE PATIENT HAD 2 PERIPHERAL SCS LEADS (OFF LABEL) FROM THE SAME LOT. IT WAS REPORTED THE PATIENT EXPERIENCED PINCHING WHEN USING STIMULATION. REPROGRAMMING DID NOT RESOLVE THE ISSUE. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT'S SCS SYSTEM WAS EXPLANTED HAD HER PNS SYSTEM REMOVED AND REPLACED (REFERENCE MFR 1627487-2014-26519 FOR IPG ISSUE). STIMULATION WAS RESTORED AND THE PATIENT IS NO LONGER EXPERIENCED PINCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364041 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4358131

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other IMPLANT DATE:| SCS IPG: MODEL 3716