BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MQUATTRODE

    MDR report key: 3133474 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-06313
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 1627487-2013-06314. THE PATIENT WAS IMPLANTED WITH TWO LEADS (3146) FROM THE SAME LOT FOR SCS THERAPY AND TWO WIDE SPACE LEADS (3163) FROM THE SAME LOT FOR PNS THERAPY. IT WAS REPORTED THE PATIENT WAS NO LONGER EXPERIENCING LEG PAIN AND NO LONGER USING THE SCS SYSTEM. THE PATIENT ASKED THAT THE SCS SYSTEM BE REMOVED. DURING THE REMOVAL OF THE SYSTEM THE PNS SYSTEM WAS TESTED INTRA-OPERATIVE AND IT WAS FOUND THAT TWO OF THE LEADS CONTACTS WERE INVALID. THE SCS SYSTEM WAS REMOVED AND THE PNS LEADS WERE REPLACED WITH NEW ONES. EFFECTIVE STIMULATION WAS CAPTURED POST OPERATIVE AND THE PATIENT'S ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223170 MQUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3163 3240557

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3341| SCS ANCHOR: MODEL 1192| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS ANCHOR: MODEL 1192| SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3341| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE: