BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 4113017 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-08294
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 29, 2014
    Report Date
    March 12, 2015
    Manufacturer
    ST JUDE MED - NEUROMODULATION
    Product Code
    GZB
    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.

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2 . REFERENCE MFR. REPORT#: 1627487-2014-08293.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2014-08293. IT WAS REPORTED THE PT IS EXPERIENCING PAIN AT HER SCS IPG SITE WITH STIMULATION BOTH ON AND OFF. ADDITIONALLY, IT WAS REPORTED THE PT HAS INVALID IMPEDANCE READINGS FROM HER SCS LEAD. AN SJM REP MET WITH THE PT AND CONFIRMED INVALID IMPEDANCES. THE PT'S LEAD ALSO APPEARS TO BE FRACTURED. THE PT IS CONSULTING WITH HER PHYSICIAN REGARDING POSSIBLE SURGICAL INTERVENTION TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575195 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3219 2822526

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other IMPLANT DATE:| SCS EXTENSION, MODEL 3383 (X2)