BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTIVE KNEE SYSTEM, RIGHT & LEFT, STANDARD

    MDR report key: 18861530 · Received March 7, 2024

    Report

    Report Number
    3011466827-2024-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 11, 2024
    Report Date
    February 29, 2024
    Manufacturer
    MOTIVE HEALTH, INC.
    Product Code
    IPF
    UDI-DI
    00850022650345
    PMA / PMN Number
    K220738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, THE CUSTOMER CONTACTED MOTIVE CUSTOMER SERVICE STATING THAT HE USED THE MOTIVE DEVICE TO TREAT HIS RIGHT KNEE. AFTER THE SECOND TREATMENT, THE CUSTOMER NOTICED SOME GEL PULLED AWAY FROM THE PAD AND STAYED ON HIS LEG; EACH TREATMENT THEREAFTER THE GEL DEGRADED FURTHER. THE PAD READ 68% OF USAGE ON THE APP AND THE CUSTOMER FOUND TWO BURN MARKS ON HIS LEG. IT WAS REPORTED BY THE CUSTOMER THAT ONE OF THE BURNS WAS DEEP. THIS CUSTOMER REPORTED THAT HE HAD COMPLETED 6 TREATMENTS: 10 MIN (1); 30 MINUTES (2), 30 MINUTES (3); 30 MINUTES (4); 30 MINUTES (5); 30 MINUTES (6). INITIALLY THE CUSTOMER USED A DIME SIZE ABOUT OF ELECTRODE GEL ON HIS LEG BEFORE TREATMENT; HOWEVER, THE TREATMENT DISCOMFORT PROMPTED HIM TO INCREASE THE AMOUNT TO ELECTRODE GEL THAT WAS USED ON HIS LEG BEFORE TREATMENT. TREATMENT TIME AND LEVELS: THERAPY TIME (MINUTES): VMO INTENSITY @START VMO INTENSITY @END RF INTENSITY @START RF INTENSITY @END 1 MINUTES ON (B)(6)2024) , 5 40 2 40 29 MINUTES ON (B)(6) 2024) , 52 58 39 46 30 MINUTES ON (B)(6) 2024) , 61 67 54 58 30 MINUTES ON (B)(6) 2024) , 60 72 52 68 30 MINUTES ON (B)(6) 2024 , 59 67 63 72 30 MINUTES ON (B)(6) 2024 . 60 55 57 54 A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THIS DEVICE INCLUDING THE STIM GENERATOR, GARMENT AND ELECTRODES HAD MET ALL THE APPLICABLE MANUFACTURING SPECIFICATIONS. THE CUSTOMER DISCARDED THE COMPONENT / THERAPY PAD IT WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE CUSTOMER CONTACTED MOTIVE CUSTOMER SERVICE STATING THAT HE USED THE MOTIVE DEVICE TO TREAT HIS RIGHT KNEE. AFTER THE SECOND TREATMENT, THE CUSTOMER NOTICED SOME GEL PULLED AWAY FROM THE PAD AND STAYED ON HIS LEG; EACH TREATMENT THEREAFTER THE GEL DEGRADED FURTHER. THE PAD READ 68% OF USAGE ON THE APP AND THE CUSTOMER FOUND TWO BURN MARKS ON HIS LEG. IT WAS REPORTED BY THE CUSTOMER THAT ONE OF THE BURNS WAS DEEP. THS CUSTOMER HAD COMPLETED 6 TREATMENTS: 10 MIN (1); 30 MINUTES (2), 30 MINUTES (3); 30 MINUTES (4); 30 MINUTES (5); 30 MINUTES (6). INITIALLY THE CUSTOMER USED A DIME SIZE ABOUT OF ELECTRODE GEL ON HIS LEG BEFORE TREATEMENT; HOWEVER, THE TREATMENT DISCOMFORT PROMPTED HIM TO INCREASE THE AMOUNT TO ELECTRODE GEL THAT WAS USED ON HIS LEG BEFORE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379096 MOTIVE KNEE SYSTEM, RIGHT & LEFT, STANDARD MOTIVE KNEE SYSTEM, RIGHT & LEFT, STANDARD IPF MOTIVE HEALTH, INC. OT01-1002 Y081423-09 00850022650345

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other