BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3012235 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-00159
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    December 30, 2012
    Report Date
    February 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 (AUSTRALIA) IS EXPERIENCING A STINGING AND ACHING PAIN AT THE PADDLE SITE. THE DISCOMFORT IS SAID TO OCCUR WHEN THE PATIENT LEANS ON AN OBJECT. THIS SITUATION WILL CONTINUE TO BE MONITORED. REVISION OF THE LEAD IS BEING CONSIDERED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104750 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3704908

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1194| SCS IPG: MODEL 3716| IMPLANT:| SCS ANCHOR: MODEL 1192