BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2821149 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-06647
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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

    IT WAS REPORTED THE PATIENT IS EXPERIENCING DISCOMFORT AND REDNESS AT THE LEAD SITE. IT WAS ALSO REPORTED THE PATIENT HAS A SMALL OPENING IN THE WOUND, AS WELL AS PUS PRESENT AT THE LEAD SITE. THE PATIENT IS SCHEDULED TO UNDERGO SURGICAL INTERVENTION ON A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3577060

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3716