BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2881330 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-02835
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 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 4 OF 5. REFERENCE MFR REPORTS: 1627487-2012-02832, 1627487-2012-02833, 1627487-2012-02834, 1627487-2012-02836. THE PATIENT RECEIVED TWO PNS SYSTEMS (OFF-LABEL) WHICH INCLUDED SIX PERCUTANEOUS LEADS FROM FIVE SEPARATE LOTS. IT WAS REPORTED TWO OF THE PATIENT'S LEADS (IN THE RIGHT TEMPLE AND SUPRAORBITAL REGIONS) EXHIBITED INVALID IMPEDANCE READINGS. REPROGRAMMING PROVIDED EFFECTIVE STIMULATION IN THE SUPRAORBITAL AREA BUT NOT IN THE TEMPLE. IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RESOLVE THE ISSUE. AS IT IS UNKNOWN WHICH LEADS ARE AFFECTED, ALL OF THE PATIENT'S LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3149 3229622

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SCS IPG: MODEL 3716 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3346 (2)