BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINAL CORD STIMULATOR

    MDR report key: 18595828 · Received January 26, 2024

    Report

    Report Number
    MW5150823
    Event Type
    Other
    Date Received
    January 26, 2024
    Report Date
    January 26, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED TO REPORT THAT HE RECEIVED A LETTER FROM ABBOTT ABOUT HIS SPINAL CORD STIMULATOR (SCS). THE LETTER PROVIDES INSTRUCTION ABOUT HIS STIMULATOR, AND THAT IF OR WHEN HE IS TO UNDERGO A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE THAT HE WOULD NEED TO PUT HIS STIMULATOR INTO MRI MODE. THE LETTER INSTRUCTED HIM TO CALL THE FDA TO LET THEM KNOW HE HAS RECEIVED THIS LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796936 SPINAL CORD STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other