BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2903143 · Received January 2, 2013

    Report

    Report Number
    1627487-2012-03959
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODUALTION
    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 INFORMATION 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 4 PERIPHERAL SCS LEADS (OFF-LABEL) WITH THE SAME LOT NUMBERS. IT WAS REPORTED, THE PT REQUESTED THAT HIS PERIPHERAL SCS SYSTEM BE REMOVED DUE TO NO LONGER LIKING SYSTEM STIMULATION. FOLLOW-UP IDENTIFIED THE PT'S PERIPHERAL SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODUALTION 3166 3543278

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3341(2)| IMPLANT DATE:| IMPLANT DATE: