BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3960993 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-24043
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 30, 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-24042. IT WAS REPORTED DURING THE POST-OPERATIVE APPOINTMENT FOLLOWING THE PATIENT'S PERMANENT IMPLANT, PROGRAMMING WAS UNSUCCESSFUL AS STIMULATION COULD NOT COVER THE ENTIRE PAIN PATTERN. FOLLOW-UP IDENTIFIED A SECOND REPROGRAMMING ATTEMPT WAS UNSUCCESSFUL AS UNINTENDED RIB STIMULATION AND INCOMPLETE COVERAGE OCCURRED. IT WAS ALSO REPORTED REPROGRAMMING COULD NOT BE COMPLETED DUE TO THE PATIENT EXPERIENCING HEAD PRESSURE. THE NEXT COURSE OF ACTION IS UNDETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429083 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 4420330

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other IMPLANT DATE:| SCS IPG: MODEL 3789| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)