BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3032260 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-01347
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    DEVICE 4 OF 4. REFERENCE MFR REPORT: 1627487-2013-1344, 1345, 1346. THE PT HAS TWO ANCHORS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT'S IPG WAS REPOSITIONED DUE TO DISCOMFORT AT THE IPG SITE ON (B)(6) 2013. THE IPG WAS MOVED FROM THE FRONT TO THE RIGHT BACK. IT WAS ALSO REPORTED THE PT WAS EXPERIENCING DISCOMFORT AT THE ANCHOR SITE. THE PHYSICIAN REMOVED THE ANCHORS AND SUTURED THE LEADS IN PLACE. THE ISSUE IS NOW RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130578 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3319721

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention