BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2821143 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-02567
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    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 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-02566. THE PT UNDERWENT A PROCEDURE TO HAVE A CERVICAL SCS SYSTEM IMPLANTED. IT WAS REPORTED THE PHYSICIAN HAD DIFFICULTY WITH PLACEMENT OF THE SURGICAL LEADS; THEREFORE, HE PULLED OUT THE LEADS AND IMPLANTED A DIFFERENT MODEL LEAD. IT WAS REPORTED THE SURGERY WAS EXTENDED BY APPROX 45 MINS DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3268 3776062

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS LEAD: MODEL 3219