BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44C

    MDR report key: 3110737 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02652
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    October 17, 2012
    Report Date
    November 12, 2012
    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 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 PT'S STIMULATION WAS AUTO-REDUCING. DIAGNOSTIC TESTING SHOWED MULTIPLE LEAD CONTACTS HAD INVALID IMPEDANCE READINGS. REPROGRAMMING WAS TEMPORARILY ABLE TO PROVIDE EFFECTIVE STIMULATION. FOLLOW-UP INDICATED ALL LEAD CONTACTS HAD IMPEDANCE ISSUES EXCEPT FOR ONE. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD ON (B)(6) 2012. IT WAS REPORTED ADEQUATE STIMULATION COVERAGE WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204791 LAMITRODE 44C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3245 3337705

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (3)| IMPLANT DATE:| SCS EXTENSION, MODEL 3343| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3163 (2)| SCS IPG, MODEL 3716