MAUDE Adverse Event Report: BLUEWIND MEDICAL LTD REVI SYSTEM; IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE

Model Number	KA-9000-0001_US_CM
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Failure to Interrogate (1332)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the discussion with the bwm team and the communication with the patient in her follow-up meeting., the patient had been using the treatment from the us trial, and the last treatment per the remote monitoring log was (b)(6) 2025.In the meeting on (b)(6) the patient did not want to explant the device after determination that the implant is not responding.
Event or Problem Description
The patient reports that she has not been able to initiate treatments for the last couple of days.She charges her ecu, she gets rapid beeping, but when she presses the power button there is no response, there is never a switch to the green light.Ps did a hard reset with the patient, then when the patient attempted to start a treatment she reported hearing clicking noises from the wearable, then a red light, then the device shut off.

• Brand Name: REVI SYSTEM
• Common Device Name: IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE
• Manufacturer (Section D): BLUEWIND MEDICAL LTD; 6 maskit street; herzliya, tel aviv 46140 02; IS 4614002
• Manufacturer (Section G): BLUEWIND MEDICAL LTD; 6 maskit street; herzliya, tel aviv 46140 02; IS 4614002
• Manufacturer Contact: himansu parikh ; 6 maskit street; herzliya, tel aviv 46140-02 ; IS 4614002
• MDR Report Key: 22919077
• Report Number: 3012239564-2025-00014
• Device Sequence Number: 9676607
• Product Code: QXM
• UDI-Device Identifier: 07290017912226
• UDI-Public: 07290017912226
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K240037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: KA-9000-0001_US_CM
• Device Catalogue Number: KA-9000-0001_US_CM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female