BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMTITRODE TRIPOLE 16C

    MDR report key: 2875199 · Received December 13, 2012

    Report

    Report Number
    1627487-2012-02824
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    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 DID NOT HAVE EFFECTIVE STIMULATION COVERAGE. THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT'S LEAD WITH A DIFFERENT MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMTITRODE TRIPOLE 16C SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3214 114302

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3716