BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATRRODE

    MDR report key: 3960887 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-05514
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    March 3, 2010
    Report Date
    July 1, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. REF MFR REPORT#: 1627487-2014-05515. THE PT HAS TWO, 3163 LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT HAS NEVER RECEIVED EFFECTIVE COVERAGE. REPROGRAMMING ATTEMPTS TO PROVIDE RESOLUTION HAVE BEEN UNSUCCESSFUL. IN RETURN, THE PT HAS CHOSEN TO UNDERGO PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427086 QUATRRODE SCS LEAD GZF ST JUDE MEDICAL - NEUROMODULATION 3163 2807602

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other SCS EXTENSION: MODEL 3383| IMPLANT DATE:| SCS IPG: MODEL 3716| SCS EXTENSION: MODEL 3342| IMPLANT DATE:| SCS ANCHORS: MODEL 1192(X2)| IMPLANT DATE:| SCS EXTENSION: MODEL 3342| IMPLANT DATE:| IMPLANT DATE: