BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44C LEAD KIT 60CM LENGTH

    MDR report key: 6191366 · Received December 20, 2016

    Report

    Report Number
    1627487-2016-06523
    Event Type
    Injury
    Date Received
    December 20, 2016
    Report Date
    December 21, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2016-06524. IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION THERAPY FROM HER SCS SYSTEM. THE PATIENT STATED HER LEADS HAVE MOVED. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE. DEVICE 1 EXPIRATION & MANUFACTURING DATE: 03 / 2006; 03 / 2004.

    Description of Event or Problem · 1

    FOLLOW UP IDENTIFIED THE PATIENT HAD HER SCS LEAD REPLACED WITH A NEW ONE. ADDITIONAL FOLLOW UP IDENTIFIED THE PATIENT'S SCS SYSTEM WAS PROGRAMMED AND THE PATIENT REPORTED RECEIVING EFFECTIVE STIMULATION COVERAGE OF ALL OF HER PAIN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839958 LAMITRODE 44C LEAD KIT 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3245 26785

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3716, SCS IPG