BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE

    MDR report key: 2971752 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-05157
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE PT HAS A LEAD FOR OFF-LABEL USE. IT WAS REPORTED THE PT IS EXPERIENCING AUTO-REDUCTION ON ALL OF HIS PROGRAMS. IN TURN, THE PT IS UNABLE TO INCREASE STIMULATION. AN IMPEDANCE CHECK WAS PERFORMED AND REVEALED INVALID CONTACTS. THE PT WILL MEET WITH HIS DOCTOR TO UNDERGO X-RAYS FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42024 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3218951

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE:| SCS ANCHOR, MODEL 1192