BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3121892 · Received May 15, 2013

    Report

    Report Number
    1627487-2013-05686
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 22, 2013
    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 WAS ADMITTED TO THE HOSPITAL, AND STAYED FOR THREE DAYS DUE TO PAIN AT THE LEAD SITE. X-RAY AND CT SCAN RESULTS REVEALED NO ANOMALIES. OVER TIME THE PAIN HAS SUBSIDED, BUT HAS NOT COMPLETELY GONE AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215078 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3863061

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R IMPLANT:| IMPLANT:| SCS IPG: MODEL 3788| SCS ANCHORS, MODEL: 1194 (X2)