BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE

    MDR report key: 3250110 · Received July 23, 2013

    Report

    Report Number
    1627487-2013-04937
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    February 28, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2013-04938. THE PATIENT REPORTED SHE HAD NOT BEEN USING THE STIMULATION OFTEN IN THE PAST 3 MONTHS BECAUSE IT WAS NOT HELPING WITH HER PAIN. IT WAS REPORTED THE PATIENT HAD BEEN REPROGRAMMED PREVIOUSLY. THE PATIENT WAS IMPLANTED FOR LOW BACK AND LEG PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342816 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL, NEUROMODULATION 3163 3209004

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR IMPLANT DATE:| SCS IPG: MODEL 3788