BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3161498 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-01633
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 HAD TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION. THE PT'S ENTIRE SCS SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249282 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3156 A11591

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SCS IPG: MODEL 3408| IMPLANT DATE:| SCS EXTENSION: MODEL 3341| IMPLANT DATE: