BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS

    MDR report key: 2884797 · Received December 3, 2012

    Report

    Report Number
    1627487-2012-02734
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 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 RECEIVED AN TRIAL SCS SYSTEM ON (B)(6) 2012. IT WAS REPORTED THE PT RECEIVED A '1202' ERROR ON HER MTS WHICH INDICATES THE '+' BUTTON IS STUCK. THE PT STATED SHE WAS ABLE TO RESUME USE OF THE SYSTEM DESPITE THE ERROR BUT THE AMPLITUDE INCREASED TO MAXIMUM BY ITSELF. THE SJM REPRESENTATIVE ADVISED THE PT THE MTS SHOULD NOT ALLOW STIMULATION TO RESUME IF THE 1202 ERROR WAS RECEIVED. IT WAS REPORTED THE PT WILL MEET WITH THE SJM REPRESENTATIVE FOR TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS MTS SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3510 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR SCS LEAD: MODEL 3086 (2)| IMPLANTED: