BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4173856 · Received October 10, 2014

    Report

    Report Number
    1627487-2014-15741
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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

    THE PATIENT HAD 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED, THE PATIENT ((B)(6)) EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE PATIENT'S SCS SYSTEM WAS ELECTIVELY EXPLANTED FOR THE PATIENT TO HAVE A CONTRA-INDICATED PROCEDURE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643053 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3189 3782277

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other IMPLANT:| SCS IPG: MODEL 3788