BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4142918 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-01621
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 6, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 INFO 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

    THE PATIENT RECEIVED 4 PNS LEADS (OFF-LABEL USE) FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IS WITHOUT STIMULATION AT THE LEFT BACK-SIDE OF THE HEAD. REPORTEDLY, UNDESIRED STIMULATION CAN BE FELT BETWEEN THE SHOULDER BLADES. X- RAYS WERE TAKEN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590826 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3169 4379021

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL, 1192 (2)| IMPLANT DATE:| SCS EXTENSION: MODEL, 3341| IMPLANT DATE:| SCS IPG: MODEL, 3788