BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2881359 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-02810
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LWS
    PMA / PMN Number
    K072462
    Adverse Event
    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 1 OF 2. REF MFR REPORT: 1627487-2012-02811. IT WAS REPORTED, THE PT HAD INEFFECTIVE STIMULATION COVERAGE. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE PT'S LEADS WITH TWO OCTRODE LEADS TO GIVE THE PT LOW BACK COVERAGE. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LWS ST. JUDE MEDICAL - NEUROMODULATION 3163 3244684

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS IPG: MODEL 3788