BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44, 60 CM LEAD

    MDR report key: 2211057 · Received August 5, 2011

    Report

    Report Number
    1627487-2011-07024
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 RECEIVED A SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT PROGRAMMER (PP) WAS BLANK. ATTEMPTS TO ADJUST THE CONTRAST WERE UNSUCCESSFUL. IT WAS REPORTED THE PT DOES HAVE STIMULATION. FOLLOW UP INDICATED THAT PT WAS SENT ANOTHER PROGRAMMER. THE PT STATED THAT STIMULATION IS FELT ON HIS RIGHT SIDE, BUT NOT ON HIS LEFT SIDE WHERE STIMULATION IS NEEDED. REP MET WITH THE PT ON (B)(6) 2011 IN ORDER TO PROGRAM THE PT'S NEW PROGRAMMER. PT NOW HAS PROGRAMS LOADED INTO NEW PROGRAMMER AND THE PROGRAMMER HAS BEEN AUTHORIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44, 60 CM LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3244 115321

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SCS EXTENSION: MODEL 3386| IMPLANTED: