BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3052626 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-05463
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 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

    IT WAS REPORTED THE PATIENT HAD FALLEN. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED OVERSTIMULATION THAT CAUSED HER TO GO THE EMERGENCY ROOM. AN IMPEDANCE CHECK REVEALED NO ANOMALIES. REPROGRAMMING HELPED ADDRESS THE ISSUE. REGARDLESS, THE PATIENT PLANS TO UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133719 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3543342

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R SCS IPG: MODEL 3716| IMPLANT: