BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE S8

    MDR report key: 2884794 · Received December 3, 2012

    Report

    Report Number
    1627487-2012-13144
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 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

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2012-13143. BOTH LEADS ARE BEING REPORTED, SINCE IT IS UNK WHICH LEAD IS RELATED TO THIS EVENT. IT WAS REPORTED THE PT WAS NOT RECEIVING EFFECTIVE THERAPY FROM HER SCS SYSTEM. THE PT HAS REQUESTED TO HAVE THE SCS SYSTEM EXPLANTED. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 345424

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR IMPLANTED:| SCS IPG: MODEL 3716