BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM SCS

    MDR report key: 19127767 · Received April 16, 2024

    Report

    Report Number
    MW5153922
    Event Type
    Injury
    Date Received
    April 16, 2024
    Report Date
    April 12, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE A RECALLED ABBOTT PROCLAIM SCS (SPINAL CORD STIMULATOR) CURRENTLY IMPLANTED AND CANNOT GET NEEDED MEDICAL CARE FOR AN URGENT HIP REPLACEMENT BECAUSE THE UNIT WON'T GO INTO MRI MODE TO ALLOW PRE-OP IMAGING TO BE DONE. I AM IN EXTREME PAIN BECAUSE OF THIS AND MY QUALITY OF LIFE IS NON-EXISTENT AT THIS POINT. CONTACT FROM ABBOTT HAS BEEN SPARSE AT BEST, LAST CONTACT HAS NOT BEEN RESPONDED TO. I WILL BE SEEKING REMOVAL OF THE UNIT AND ALL LEGAL REMEDIES AS THERE HAVE BEEN ADDITIONAL ISSUES AS WELL. PLEASE CONTACT ME FOR FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539393 PROCLAIM SCS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other| S