BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44

    MDR report key: 2820505 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-02618
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 10, 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 INFORMATION 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 WAS UNABLE TO INCREASE OR TURN ON STIMULATION WITH HER PROGRAMMER. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE READINGS ON ALL LEAD CONTACTS. IT WAS REPORTED THE PT HAD NOT HAD ANY FALLS AND X-RAYS WILL BE DONE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3244 114844

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR IMPLANT:| SCS IPG: MODEL 3716