BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3123586 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-03648
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 2 OF 4. REFERENCE MFR REPORTS: 1627487-2013-03647, 1627487-2013-03649, AND 1627487-2013-03650. THE PATIENT HAS 2 MODEL 3166 SCS LEADS AND 2 MODEL 3149 SCS LEADS, ALL HAVE DIFFERENT LOT NUMBERS. IT IS UNK WHICH SCS LEAD IS RELATED TO THIS ISSUE; THEREFORE, ALL ARE BEING REPORTED. THE PATIENT REPORTED SHE IS EXPERIENCING PAIN AND TENDERNESS AT HER SCS LEAD SITE. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219660 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3166 3250343

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SCS EXTENSION: MODEL 3346 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788