BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2831287 · Received November 6, 2012

    Report

    Report Number
    1627487-2012-03666
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 15, 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

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALY RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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. REF MFR REPORTS: 1627487-2012-03667 AND 1627487-2012-03668. THE PT RECEIVED 2 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PHYSICIAN DIAGNOSED THE PT WITH AN INFECTION AT THE BACK OF THE HEAD AFTER THE PT REPORTED PRESSURE IN THE AREA ALONG WITH CLEAR FLUID AND PUS. THE PT ALSO REPORTED EXPERIENCING CHILLS. THE PT WAS ADMITTED TO THE HOSP THROUGH THE ER AND HIS SCS SYSTEM WAS EXPLANTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 2803403

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R SCS IPG: MODEL 3788| IMPLANT DATE: