BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 2881495 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-11836
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-11837. IT WAS REPORTED, THE PT WAS RECEIVING TOO MUCH STIMULATION ON THE LEFT SIDE OF HIS BODY BUT NOT ENOUGH STIMULATION ON THE RIGHT SIDE. THE PHYSICIAN OPTED TO ADD A PERIPHERAL SCS SYSTEM WITH TWO NEW LEADS TO PROVIDE STIMULATION COVERAGE. IT WAS REPORTED, THE PT RECEIVED STIMULATION COVERAGE WITH THE NEW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3244 3269335

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3383| IMPLANT DATE:| IMPLANT DATE: