BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 4143089 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-12636
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 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 AN 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 #1627487-2014-12635. NOTE THE PATIENT RECEIVED 2 QUATTRODE LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AND OVERSTIMULATION WHEN SHE PRESSES ON THE LEAD AND THE AREA FEELS BRUISED. THE X-RAYS REVEALED THE LEADS MIGRATED. THE PATIENT IS PENDING A PHYSICIAN APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591023 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3422941

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other SCS IPG: MODEL 3716| IMPLANT DATE: