BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLAIM

    MDR report key: 6893997 · Received September 26, 2017

    Report

    Report Number
    6893997
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    June 16, 2017
    Report Date
    September 19, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    GZB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A ST. JUDE ELITE PROCLAIM INTERNAL PULSE GENERATOR WAS IMPLANTED. AFTER PLACEMENT, THE PATIENT, WHO HAS FIBROMYALGIA, CONTINUED TO HAVE LOW BACK PAIN. THE PATIENT RETURNED TO THE CLINIC FOR POST-OPERATIVE FOLLOW UP A FEW WEEKS LATER. AFTER SIGNIFICANT INTERROGATION, IT WAS DETERMINED THAT THE SYSTEM WAS MALFUNCTIONING (ST. JUDE COMPANY REPRESENTATIVE WAS PRESENT). DAYS AFTER THE FOLLOW UP VISIT, THE SYSTEM WAS REPLACED IN THE BNI-OR. THE COMPANY REPRESENTATIVE TOOK THE EXPLANTED SYSTEM FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674516 PROCLAIM STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB ST. JUDE MEDICAL, INC. 160854D2

    Patients

    Seq Age Sex Outcome Treatment
    1