BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C LEAD, 60 CM

    MDR report key: 5112107 · Received September 29, 2015

    Report

    Report Number
    1627487-2015-06371
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    September 10, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION FROM HIS SCS SYSTEM. SYSTEM DIAGNOSTICS INDICATED THE PATIENT'S PROGRAM WAS AUTO-REDUCING AND INVALID IMPEDANCES WERE PRESENT ON THE PATIENT'S LEAD. AN SJM REPRESENTATIVE MET WITH THE PATIENT FOR SYSTEM REPROGRAMMING BUT WAS UNABLE TO PROVIDE EFFECTIVE STIMULATION THROUGH REPROGRAMMING. THE PATIENT WILL FOLLOW UP WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643344 LAMITRODE TRIPOLE 16C LEAD, 60 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3214 113671

    Patients

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