BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2881357 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-02814
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    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

    THE PT RECEIVED TWO QUATTRODE LEADS FROM THE SAME LOT NUMBER AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT HAD EXPERIENCED A FALL AND ONE OF HER LEADS WAS FOUND TO HAVE MIGRATED. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD WITH A DIFFERENT MODEL ON (B)(6) 2012. IT WAS REPORTED THE PT REGAINED STIMULATION COVERAGE AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 3604107

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SCS ANCHOR: MODEL 1192 (3)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3286| IMPLANT DATE:| SCS EXTENSION: MODEL 3343