BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4212900 · Received October 24, 2014

    Report

    Report Number
    1627487-2014-23705
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    May 1, 2013
    Report Date
    September 30, 2014
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION SYSTEMS
    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

    (B)(4). 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 3. REFERENCE MFR. REPORT#: 1627487-2014-23704, 23707. IT WAS REPORTED THE PATIENT IS EXPERIENCING OVERSTIMULATION SENSATIONS AT THE OCCIPITAL (OFF LABEL USE) LEAD AND IPG SITES. THE PATIENT STATED SHE HAS FELT THE SENSATIONS SINCE IMPLANT BUT RECENTLY THE OVERSTIMULATION FEELS WORSE THAN THE PAIN RELIEF SHE IS RECEIVING FROM HER SCS SYSTEM. X-RAYS ARE TO BE TAKEN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679022 QUATTRODE GZF ST. JUDE MEDICAL NEUROMODULATION SYSTEMS 3166 3977535

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other SCS EXTENSION, MODEL 3346 (2),| SCS LEAD, MODEL 3149 (2),| IMPLANT DATE:| IMPLANT DATE: