BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850220 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-00288
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PT (AUSTRALIA) EXPERIENCED OVERSTIMULATION. X-RAY IMAGERY REVEALED MIGRATION OF BOTH LEADS. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291502 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other IMPLANT DATE:| SCS IPG: MODEL 3788