BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3133355 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-05700
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    December 18, 2012
    Report Date
    April 23, 2013
    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 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

    IT WAS REPORTED THE PT'S HAS BEEN EXPERIENCED PAIN THAT SPREADS FROM HER BACK TO HERS RIBS. THE PAIN OCCURS WHETHER STIMULATION IS ON OR OFF, AND HAS BEEN PRESENT SINCE BEING IMPLANTED. AS A RESULT, THE PT WILL MEET WITH AN SJM REP TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223412 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3822373

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788