BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3252197 · Received July 25, 2013

    Report

    Report Number
    1627487-2013-06667
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    8072462
    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 4 OF 4. REFERENCE MFR REPORT: 1627487-2013-06664. REFERENCE MFR REPORT: 1627487-2013-06665. REFERENCE MFR REPORT: 1627487-2013-06666.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348315 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 3530253

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other IMPLANTED:| SCS EXTENSION: MODEL 3341 (X2)| IMPLANTED:| SCS ANCHOR: MODEL 1192 (X2)