BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE S8

    MDR report key: 3831920 · Received March 6, 2014

    Report

    Report Number
    1627487-2014-00119
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 12, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT ((B)(6)) IS NOT RECEIVING EFFECTIVE THERAPY COVERAGE AND HAS LOST STIMULATION FROM HER RIGHT HIP TO HER RIGHT LEG. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ONE OF THE PT'S LEADS. EFFORTS TO RECAPTURE EFFECTIVE STIMULATION VIA REPROGRAMMING WERE UNSUCCESSFUL. AN APPOINTMENT WILL BE SCHEDULED FOR FURTHER ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135142 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3269287

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK IMPLANT DATE:| SCS IPG: MODEL 3716