BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4162894 · Received October 8, 2014

    Report

    Report Number
    1627487-2014-20301
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT# 1627487-2014-20302. THE PT RECEIVED 4 SCS LEADS (OFF-LABEL). TWO LEADS OF MODEL# 3166 HAS THE SAME LOT NUMBER. ANOTHER TWO LEADS OF MODEL# 3159 HAS THE SAME LOT NUMBER. IT WAS REPORTED THE PT EXPERIENCED INEFFECTIVE AND POSITIONAL STIMULATION. REPROGRAMMING WAS ATTEMPTED TO NO AVAIL. X-RAYS WILL BE TAKEN AS A NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631565 QUATTRODE SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3166 2790227

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other SCS EXTENSION: MODEL 3346| SCS IPG: MODEL 3716| IMPLANT DATE:| IMPLANT DATE: