BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 3010508 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-02354
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 19, 2013
    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 PATIENT SUDDENLY LOST STIMULATION AND HER PROGRAMS WERE AUTO-REDUCING. DIAGNOSTIC TESTING REVEALED "0 OHMS" ON ALL LEAD CONTACTS. IT WAS REPORTED SURGICAL INTERVENTION WILL MOST LIKELY BE UNDERTAKEN TO RESOLVE THE ISSUE AS THE PHYSICIAN REFERRED THE PATIENT TO A SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108415 LAMITRODE TRIPOLE 16C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3214 83975

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS IPG: MODEL 3716| IMPLANT DATE: