BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 6141101 · Received December 2, 2016

    Report

    Report Number
    1627487-2016-06147
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    November 9, 2016
    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
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2016-06148. THE LEADS WERE PLACED OCCIPITAL (OFF LABEL USE.) IT WAS REPORTED THE PATIENT RECEIVED INEFFECTIVE STIMULATION AND AN UNCOMFORTABLE PINCHING SENSATION WHEN STIMULATION WAS ON. IMAGES TAKEN SHOWED NO ANOMALIES. ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY WHERE THE LEAD WAS REPOSITIONED. INTER-OP TESTING CONFIRMED THE PATIENT'S LEAD WAS MORE COMFORTABLE. THE PATIENT WAS PROGRAMMED IN RECOVERY ROOM AND EFFECTIVE STIMULATION WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791456 QUATTRODE LEAD WIDE SPACED, 90 CM SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3169 5241219

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 1192(2), SCS ANCHOR| MODEL 3169(2), SCS LEAD| MODEL 3341(2), SCS EXTENSION| MODEL 3771, SCS IPG