BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOMOPRO 2X

    MDR report key: 24389515 · Received February 19, 2026

    Report

    Report Number
    MW5184094
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    October 16, 2025
    Report Date
    February 14, 2025
    Manufacturer
    MYOMO, INC.
    Product Code
    IQZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM A CVA SURVIVOR, FOLLOWING A REFERRAL I WAS ASSESSED FOR A MOYOMOPRO ORTHOSIS FOR MY WEAK L. ARM, ON (B)(6) 2025. THEY BILLED MEDICARE AND GOT PAID IN (B)(6), BUT I ONLY RECEIVED ORTHOSIS ON (B)(6) 2025. AFTER RECEIVING THE ORTHOSIS AND USING IT, IT WOULD SHUDDER AND JERK, CONTINUALLY DURING USE, PUTTING MY WEAK, ALREADY SUBLUXED L. SHOULDER AT RISK OF FURTHER DAMAGE. MY SHOULDER WOULD BE SORE FOR 12-24 HOURS AFTER EACH 15 MINUTE SESSION. REPEATED COMPLAINTS TO (B)(6). HAVE MET W FEABLE ATTEMPT AT HELP; THE LAST WAS BY VIDEO CALL TO (B)(4) IN (B)(6) 02/03/2026, WHICH IMPROVED THE SHUDDERING A LITTLE. THEY PUT THE ONUS ON ME TO ENGAGE A NEW O.T. TO HELP ME ADJUST TO THE SHUDDERING. I AM EXTREMELY CONCERNED THAT AT 79, I AM A POOR CANDIDATE FOR THIS DEVICE, AND I WAS WRONGLY ASSESSED FOR IT. IT SHOULD HAVE NOT BEEN RECOMMENDED FOR ME. AND NOW THE ONUS IS ON ME, FOR NOT FITTING IN WITH THEIR DEVICE. IN FACT WAY BACK IN AUGUST/SEPTEMBER WHEN I WAS BEING MEASURED FOR THE DEVICE, I REALIZED IT WAS MUCH TOO HEAVY FOR MY SUBLUXED SHOULDER AND NOT SUITABLE FOR ME; AND I CANCEL THE ORDER THEN- BEFORE THEY HAD FABRICATED ANY PARTS, BUT THEY HARASSED ME BY EMAIL, AND IN (B)(6) TOLD ME THE DEVICE WAS READY TO TRY TAKE. I CALLED MEDICARE, WHO SAID THEY HAD BEEN BILLED FOR (B)(6) AND HAD BEEN PAID IN MAY. THEY ADVISED ME TO GO AHEAD AND TRY IT, SINCE IT HAD BEEN ALREADY FABRICATED. SO ON (B)(6), I COLLECTED THE DEVICE AND TRIED IT ON AS THEY HAD INSTRUCTED BUT ON DEC MY O.T. SAID THAT THE MYOMO WAS UNHELPFUL FOR ME. SO NOW I AM IN LIMBO AND VERY CONCERNED FOR THE INTEGRITY OF MY ALREADY SUBLUXED L SHOULDER; AND THEY JUST TOLD ME BY EMAIL THAT I NEEDED TO GET A NEW O.T. TO ADJUST TO DEVICE, GET USED TO IT AND LEARN HOW TO USE. I SAID I WOULD SEE A NEW OT THEY RECOMMENDED, TO SEE WHAT THEY HAVE TO OFFER. I DO WANT TO GET BETTER BUT DO NOT WANT TO RISK MORE DAMAGE TO MY SUBLUXED SHOULDER. THEY DO NOT SHOW ANY CONCERN. THANK YOU SO VERY MUCH FOR CONSIDERATION MY STRESSFUL CASE. (B)(6), MD. THE MYOMO ENGINEERS IN (B)(6), THROUGH THEIR PROXY IN (B)(6) AND TELE CONSULTATION BY ZOOM MADE SOME ADJUSTMENTS TO THE DEVICE, WHICH HAVE HELPED ONLY A LITTLE IN REDUCING JERKING MY ALREADY SUBLUXED, WEAK SHOULDER. WHEN I TOLD THEM THE OUTCOME BY EMAIL THE REPLY PUT THE ONUS ON ME, TELLING ME I NEEDED TO SEE A NEW OCCUPATIONAL THERAPIST. I AM FRUSTRATED AND DO NOT KNOW WHAT TO DO; BUT SHALL SEE A NEW OT THEY HAVE RECOMMENDED. IT CAN BE A VERY DETRIMENTAL MACHINE FOR OLDER PATIENTS' SHOULDERS LIKE MINE. THE O.T. WHO TOLD ME ON (B)(6) 2025, MYOMO WAS NOT SUITABLE FOR ME HAD, IN FACT, BEEN TRAINED BY MYOMO/INFINITETECHNOLOGIES TO WORK ON PATIENTS WITH MYOMO. THANK YOU.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 03/30/2026 FOR MW5184094 TO UPDATE PROCODE TO IQZ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454662 MYOMOPRO 2X HAND, EXTERNAL LIMB COMPONENT, POWERED IQZ MYOMO, INC. MYOMOPRO 2X

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male ASPIRIN. | CLONIDINE.| EYE VITAMIN AREDS. | ROSUVASTATIN 5MG DAILY. | TADALAFIL.| VIT B12.| ZEAXANTHIN.