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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling/ Edema (4577); Peripheral Edema (4578)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physician did an ultrasound on the patient's ankle.The physician reports it was normal.Physician ordered a cysto to see if there are any other issues affecting the patient's uui (patient reports nocturia 1-2x per night and uui frequency of 3-4x per day, patient previously stated he wanted revi in order to not have to go to the restroom as often when flying home to (b)(6).) the patient experienced swelling that may or may not be related to the device.
Event or Problem Description
Patient swelling following treatment.Fcs reported :patient reports ankle swelling soon after use of the device, and swelling does not subside for days.Pictures are sent from patient provided to fcs.

• 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: 22790179
• Report Number: 3012239564-2025-00009
• Device Sequence Number: 8808631
• 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
• Device Implanted Year: 2024
• 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): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/11/2025
• Initial Report FDA Received Date: 08/12/2025
• 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: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian