BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3810711 · Received April 28, 2014

    Report

    Report Number
    1627487-2014-26359
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 WENT TO THE ER PRESENTING WITH URINARY RETENTION AND LEFT LEG WEAKNESS. A CT SCAN WAS TAKEN WITH NO ANOMALIES NOTED. THE PHYSICIAN DECIDED TO REMOVE THE SCS SYSTEM. FOLLOW UP INFORMATION IDENTIFIED THAT THE PATIENT CONTINUES TO EXPERIENCE DIFFICULTY IN URINATING AND RIGHT LEG WEAKNESS. THE PATIENT WAS CATHETERIZED AND REFERRED TO A UROLOGIST FOR FURTHER FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253670 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 4294651

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other IMPLANT:| SCS IPG: MODEL 3788