BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S4

    MDR report key: 4091853 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-02587
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-02588. THE PATIENT RECEIVED TWO 3246 MODEL LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION THERAPY FROM HIS SCS SYSTEM. REPROGRAMMING DID NOT RESOLVE THE ISSUE. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526124 LAMITRODE S4 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3246 4395424

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (X3)| IMPLANT DATE: