BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2940680 · Received January 29, 2013

    Report

    Report Number
    1627487-2013-02137
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 7, 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S SUTURES OPENED UP FROM THE INCISION WHERE A LEAD WAS PLACED ON (B)(6) 2012. THE PATIENT STATED SHE WENT TO THE HOSPITAL AND THE INCISION WAS SEWN BACK UP. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39231 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3776807

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3186| SCS IPG: MODEL 3716| IMPLANT: