BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3133127 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-03683
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-03682. THE PATIENT RECEIVED 4 SCS LEADS, 3 HAVE THE SAME LOT NUMBER. THE PATIENT REPORTED SHE HAS NOT USED SYSTEM STIMULATION IN YEARS DUE TO NOT RECEIVING EFFECTIVE STIMULATION IN HER PAIN PATTERN AND RECEIVING UNWANTED STIMULATION DOWN HER LEGS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223299 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3163 R119901

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention SCS EXTENSION: MODEL 3341 (2)| SCS ANCHOR, MODEL 1194 (4)| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE: