BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3110650 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-12656
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 #1627487-2013-12657. IT WAS REPORTED THE PATIENT HAS INEFFECTIVE STIMULATION. THE SJM REPRESENTATIVE ATTEMPTED TO REPROGRAM THE PATIENT TO NO AVAIL. PATIENT HAS REQUESTED THE SJM REPRESENTATIVE ATTEMPT TO REPROGRAM AGAIN. NOTE: THE PATIENT RECEIVED TWO LEADS FROM THE SAME LOT NUMBER, HOWEVER THE IMPLANT DATES WERE DIFFERENT. BOTH LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208989 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3156 39011

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788