BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2980322 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-13340
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 3 OF 3. REFERENCE MFR. REPORT: 1627487-2013-13338 AND 13339. IT WAS REPORTED THE PATIENT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION AND OPTED TO HAVE HER ENTIRE SCS SYSTEM EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77525 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3163 3258350

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention IMPLANT DATE:| SCS ANCHOR, MODEL 1192