BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2772006 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-12197
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 INFO 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 3. REFERENCE MFR REPORT #1627487-2012-12198, REFERENCE MFR REPORT #1627487-2012-12199. THE PT REPORTED SHE FELL AND SUBSEQUENTLY COULD NOT FEEL STIMULATION FROM THE OFF-LABEL OCCIPITAL LEADS. REPROGRAMMING RESOLVED THE ISSUE. A FEW DAYS LATER, THE PT COULD NOT FEEL STIMULATION AGAIN. THE SJM CS THEN MET WITH THE PT AND THE PT REPORTS FEELING A SHOCKING SENSATION IN THE TWO OCCIPITAL LEADS. NOTE THERE ARE TWO MODELS OF LEADS, TWO LEADS OF EACH MODEL. THERE ARE FOUR TOTAL LEADS, FROM THREE DIFFERENT LOT NUMBERS. ALSO NOTE TWO LEADS ARE PLACED SUPRA-ORBITAL (OFF-LABEL USE). IT WAS REPORTED THE PT HAD X-RAYS AND THERE ARE NO VISIBLE ANOMALIES WITH THE LEADS OR IPG. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3169 3713576

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention IMPLANT:| IMPLANT:| SCS IPG: MODEL 3716| SCS EXT: MODEL 3343 (2)