BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4202006 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-02734
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    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 3 OF 4. REFERENCE MFR REPORT: 1627487-2014-02732. REFERENCE MFR REPORT: 1627487-2014-02733. REFERENCE MFR REPORT: 1627487-2014-02735. IT WAS REPORTED THE PT'S SCS STIMULATION TURNS OFF WITHOUT PROMPTING. A SJM REPRESENTATIVE HAS MET WITH THE PT ON MULTIPLE OCCASIONS AND RESTORED THE PT'S STIMULATION. HOWEVER, THE PT CONTINUES TO LOSE STIMULATION. THE PT WAS MET BY A DIFFERENT SJM REPRESENTATIVE AND A SYSTEM DIAGNOSTICS SHOWED MULTIPLE INVALID LEAD CONTACTS. ADDITIONALLY, THE PT DOES NOT HAVE STIMULATION COVERAGE IN ALL OF HIS PAIN. AREA. THE PT IS PENDING A FOLLOW-UP WITH HIS PHYSICIAN TO FURTHER EVALUATE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663334 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3163 3139141

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other IMPLANTED:| SCS IPG: MODEL 3716| IMPLANTED:| SCS EXTENSION: MODEL 3343| IMPLANTED:| SCS ANCHOR: MODEL 1192