BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCELSTIM

    MDR report key: 17066044 · Received June 5, 2023

    Report

    Report Number
    2183449-2023-00002
    Event Type
    Injury
    Date Received
    June 5, 2023
    Report Date
    March 21, 2024
    Manufacturer
    ORTHOFIX
    Product Code
    LOF
    UDI-DI
    08050040997213
    PMA / PMN Number
    P210035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED AND IS PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RETURNED DEVICE WAS COMPLETED ON 09 JUN 2023. 159 THERAPIES WERE CONDUCTED. THE MOST RECENT THERAPY WAS ON MARCH 21, 2023. DURING TWO OF THESE TREATMENTS, WE MONITORED THE TEMPERATURE ON THE TRANSDUCER SURFACE, WITH THE MAXIMUM TEMPERATURE RECORDED REACHING 25.3°C. ADDITIONALLY, WE MEASURED ACOUSTIC POWER VALUES BOTH WITH AND WITHOUT THE POWER SUPPLY CONNECTED, RESULTING IN READINGS OF 120 MW AND 118 MW, RESPECTIVELY. NO TEMPERATURE-RELATED ISSUES WERE DETECTED, AND THERE WAS NO CONFIRMATION OF ANY MALFUNCTION WITH THE DEVICE.

    Description of Event or Problem · 0

    INFORMATION PROVIDED STATES THAT PATIENT WAS PRESCRIBED ACCELSTIM DEVICE (B)(6) 2022. PT SAID SHE USED DEVICE FOR 5 MONTHS WITH NO ISSUES. SHE STATED THAT SHE HAS GOTTEN BURNED TWICE, ONCE 5 WEEKS PRIOR TO CALLING CUSTOMER SERVICE AND AGAIN 3 WEEKS LATER. PT DISCONTINUED USE OF THE DEVICE. THE DEVICE WAS REPLACED WITH A NEW UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094008 ACCELSTIM BONE GROWTH STIMULATOR LOF ORTHOFIX 4300 08050040997213

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other