BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2973630 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-05235
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 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 INFO 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 2 OF 2. REFERENCE MFR REPORT#: 1627487-2013-05234. THE PT HAS THREE LEADS (TWO ARE THE SAME MODEL/LOT). IT WAS REPORTED, THE PT WAS HIT BY A BASEBALL. AFTERWARDS, THE PT BEGAN TO EXPERIENCE ABDOMINAL STIMULATION. X-RAYS WERE TAKEN AND REVEALED LEAD MIGRATION. THE PT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72365 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3389149

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT:| IMPLANT:| SCS ANCHORS: MODEL 1192 (X3)| IMPLANT:| SCS EXTENSIONS: MODEL 3342