BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44C

    MDR report key: 3820904 · Received May 13, 2014

    Report

    Report Number
    1627487-2014-12344
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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'S SCS SYSTEM WAS AUTO-REDUCING. DIAGNOSTIC TESTING REVEALED MANY INVALID CONTACTS. REPROGRAMMING WAS ABLE TO PROVIDE STIMULATION. HOWEVER, THE PATIENT LOST STIMULATION APPROXIMATELY 2 WEEKS LATER. THE PHYSICIAN EXPLANTED AND REPLACED ONE OF THE LEADS. THE PATIENT REPORTED RECEIVING EFFECTIVE STIMULATION THERAPY POST OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287512 LAMITRODE 44C SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3245 3577072

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3163| SCS IPG: MODEL 3716