BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4181347 · Received August 6, 2014

    Report

    Report Number
    1627487-2014-23522
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 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 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. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PT HAD 2 LEADS FROM THE SAME LOT IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT EXPERIENCED A CHANGE IN STIMULATION. X-RAYS REVEALED THE PT'S LEADS HAD MIGRATED. FOLLOW-UP INFORMATION REVEALED THE PT UNDERWENT SURGICAL INTERVENTION, WHERE THE LEADS WERE REMOVED AND REPLACED WITH A PADDLES LEAD. ADDITIONAL FOLLOW-UP INFORMATION REVEALED THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459029 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4432412

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3789| SCS ANCHOR: MODEL 1192