BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4151848 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-25639
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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 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 3 OF 4 REFERENCE MFR REPORT#: 1627487-2014-25637, 25638 AND 25640. THE PATIENT HAS TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IS EXPERIENCING STINGING AND BURNING AT THE IPG SITE REGARDLESS OF STIMULATION. ADDITIONALLY, IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AT THE IPG SITE AND LEAD SITES. IN TURN, THE PATIENT MET WITH THE PHYSICIAN AND DETERMINED SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622941 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3146 97341

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other IMPLANT:| SCS EXTENSIONS: MODEL 3341 (X2)