BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3960997 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-24046
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 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 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-24045. IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 TO RELOCATE THE SUPRA-ORBITAL (OFF-LABEL) LEADS DUE TO SCABBING ABOVE THE EAR AND TO PREVENT FUTURE EROSION AS WELL AS IMPROVE RIGHT SIDE COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429075 QUATTRODE SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3169 3615842

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other SCS EXTENSION: MODEL 3466 (2)| IMPLANT DATE: