BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2831292 · Received November 6, 2012

    Report

    Report Number
    1627487-2012-11632
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 3 OF 4. REF MFR REPORT: 1627487-2012-07030. REF MFR REPORT: 1627487-2012-11631. REF MFR REPORT: 1627487-2012-11633.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 3108715

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3341 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (4)