BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 2973628 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-10061
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 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
    FR
    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

    IT WAS REPORTED, THE PT ((B)(6)) WAS UNABLE TO ACHIEVE EFFECTIVE STIMULATION. DIFFERENT PROGRAMS WERE ATTEMPTED TO NO AVAIL. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCES. CONNECTIONS WERE TESTED INTRA-OPERATIVELY WITH NO ANOMALIES FOUND. THE SCS LEAD WAS ALSO TESTED INTRA-OPERATIVELY WITH INVALID IMPEDANCES IDENTIFIED FOR EACH BIPOLE TESTED. THE LEAD COULD NOT BE REPLACED AT THAT TIME DUE TO AN UNRELATED ELBOW INFECTION. THE LEAD WAS RECONNECTED TO THE IPG AND THE STIMULATOR WAS LEFT IN THE OFF POSITION. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72718 LAMITRODE 44 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3244 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention