BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE

    MDR report key: 3060229 · Received April 10, 2013

    Report

    Report Number
    1627487-2013-05494
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LWS
    PMA / PMN Number
    K072462
    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 3 OF 3. REFERENCE MFR REPORT #: 1627487-2013-05492. REFERENCE MFR REPORT #: 1627487-2013-05493. IT WAS REPORTED THE PT HAS DEACTIVATED STIMULATION DUE TO IT NOT BEING HELPFUL. IT WAS ALSO REPORTED THE PT DECLINED BEING REPROGRAMMED BY AN SJM REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153000 QUATTRODE SCS ;LEAD LWS ST. JUDE MEDICAL - NEUROMODULATION 3169 3615842

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention SCS EXTENSIONS: MODEL 3346 (X2)| IMPLANTED:| SCS IPG: MODEL 3716| IMPLANTED: