BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3960936 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-12489
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 1 OF 4. REFERENCE MFR REPORT #1627487-2014-12490. REFERENCE MFR REPORT #1627487-2014-12491. REFERENCE MFR REPORT #1627487-2014-12492. NOTE: THE PATIENT HAS 2 SYSTEMS, WITH 5 LEADS FROM 4 LOT NUMBERS. IT IS UNKNOWN WHICH SYSTEM IS CAUSING THE ISSUE, ALL POSSIBLE LOT NUMBERS ARE BEING REPORTED. IT WAS REPORTED THE PATIENT IS EXPERIENCING SHOCKING AT THE LEADS. IT WAS ALSO REPORTED THE PATIENT FEELS PINCHING UP HER BACK AND IN THE MIDDLE OF HER BACK WHEN STIMULATION ON. THE PINCHING SENSATION RESOLVES WHEN THE IPG IS TURNED OFF. THE PATIENT WANTS BOTH OF THE SYSTEMS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427090 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL -NEUROMODULATION 3163 3593592

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL: 3688 (2)| SCS EXTENSION, MODEL 3341 (2)