BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE

    MDR report key: 2926513 · Received January 16, 2013

    Report

    Report Number
    1627487-2013-00055
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 # 1627487-2013-00053 AND 1627487-2013-00054. THE PT ((B)(6)) IS CURRENTLY IMPLANTED WITH FOUR PERCUTANEOUS LEADS FROM THREE DIFFERENT LOTS. IT WAS REPORTED THE PT HAS EXPERIENCED A CHANGE IN STIMULATION AND IS CURRENTLY UNABLE TO UTILIZE SOME OF HIS PROGRAMS. ONE OF THE PT'S LEADS IS REPORTEDLY CAUSING PAINFUL STIMULATION IN THE BUTTOCK AREA. IN ADDITION, A RECENT DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ONE OF THE PT'S LEADS WHICH INHIBITS STIMULATION COVERAGE HIS LEG. A DECISION REGARDING THE NEXT COURSE OF ACTION IN THIS MATTER HAS NOT BEEN REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24255 QUATTRODE SCS LEAD LGW ST. JUDE MED - NEUROMODULATION 3146 3613376

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL: 3341| IMPLANT DATE:| SCS IPG: MODEL: 3788