BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 4180011 · Received October 15, 2014

    Report

    Report Number
    1627487-2014-21670
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    IT WAS REPORTED, THE PATIENT EXPERIENCED INEFFECTIVE PAIN RELIEF FROM THE SYSTEM. ADDITIONALLY, THE PATIENT REPORTED INCREASED PAIN AROUND THE LEAD SITE THAT WAS ATTRIBUTED TO THE PRESENCE OF FIBROUS SCARRING AND COULD NOT BE ADDRESSED VIA MEDICATION. SUBSEQUENTLY, THE ENTIRE SCS SYSTEM WAS EXPLANTED. IT WAS REPORTED THE PATIENT IS FEELING BETTER SINCE THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655850 LAMITRODE TRIPOLE 16C SCS LEAD GZB ST. JUDE MED - NEUROMODULATION 3214 2828649

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANT DATE:| SCS ANCHOR: MODEL 1194| IMPLANT DATE:| SCS IPG: MODEL 3716