BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2940666 · Received January 29, 2013

    Report

    Report Number
    1627487-2013-02134
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    November 12, 2012
    Report Date
    January 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 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: 1627487-2012-02757.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38779 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3141 68457

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS EXTENSION: MODEL 3341| SCS LEAD: MODEL 3166 (2)| IMPLANT:| IMPLANT:| IMPLANT:| IMPLANT:| SCS EXTENSION: MODEL 3341 (2)| SCS LEAD: MODEL 3169 (2)| IMPLANT:| SCS LEAD: MODEL 3141 (2)| IMPLANT:| SCS EXTENSION: MODEL 3342| IMPLANT:| SCS IPG: MODEL 3716