BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3032269 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-03447
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    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 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 3. REFERENCE MFR. REPORTS: 1627487-2013-03446 AND 1627487-2013-03448. THE PATIENT RECEIVED A TOTAL OF 4 SCS LEADS. THE 2 SCS LEADS HAVE THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT'S LEFT SCS LEAD IS CAUSING HER PAIN AS THE PATIENT CAN FEEL THE LEAD INSIDE HER. A SJM REPRESENTATIVE WAS UNABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING AS PAIN OCCURS REGARDLESS OF STIMULATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130719 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 3838916

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention SCS LEAD, MODEL 3176| SCS EXTENSION, MODEL 3346 (2)| IMPLANT DATE:| IMPLANT DATE: