BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3123531 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-01553
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 26, 2013
    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.

    Description of Event or Problem · 1

    THE PT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS NO LONGER RECEIVING STIMULATION IN HER NECK AFTER SUFFERING A FALL. X-RAYS SHOWED THE LEADS HAVE MIGRATED. SHE IS STILL RECEIVING COVERAGE IN HER UPPER SHOULDER AND SURROUNDING AREAS BILATERALLY. THE PT REPORTED THE PAIN IN HER NECK IS WORSE AFTER THE FALL AND SHE ALSO HAS SEVERE PAIN IN OTHER AREAS. THE PT PLANS TO DISCUSS OPTIONS WITH HER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219082 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3189 3234915

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788