BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 2802941 · Received October 19, 2012

    Report

    Report Number
    1627487-2012-10578
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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

    THE PT WAS TO RECEIVE AN SCS SYSTEM WHICH INCLUDED A SURGICAL LEAD. AFTER THE LEAD WAS PLACED, INTRA-OPERATIVE TESTING IDENTIFIED IMPEDANCE ISSUES. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE USING A NEW LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3214 3646152

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention