MAUDE Adverse Event Report: BLUEWIND MEDICAL LTD REVI SYSTEM; IMPLANTED TIBIAL ELECTRICAL URINARY, PRODUCT CODE: QXM

Model Number	MA-1007-0600_US_CM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neuropathy (1983)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported that she had stopped using the revi device in early (b)(6) 2026 due to feeling tingling, numbness and pain in her left leg from the bottom sole of foot up to left buttock.She reports these symptoms to have started around early (b)(6) 2025.She then stopped using revi in (b)(6) 2026 unsure if it was caused by revi.She did not see any difference in symptoms or severity when stopping revi treatments.She denies any redness, inflammation or warmth at incision site.She was diagnosed with neuropathy, but the cause is still unknown.She was prescribed medication for the neuropathy and pain.

• Brand Name: REVI SYSTEM
• Common Device Name: IMPLANTED TIBIAL ELECTRICAL URINARY, PRODUCT CODE: QXM
• Manufacturer (Section D): BLUEWIND MEDICAL LTD; 6 maskit street; 1389 center drive suite; park city, ut 84098, usa UT
• Manufacturer (Section G): BLUEWIND MEDICAL LTD; 6 maskit street.; p.o. box 4100 herzliya 461402,; herzliya, israel 46140 2; IS 461402
• Manufacturer Contact: angel estrada ; 1389 center drive suite 200; park city, ut 84098, usa; park city, UT ; 7742842463
• MDR Report Key: 25032607
• Report Number: 3012239564-2026-00020
• Device Sequence Number: 10126700
• Product Code: QXM
• UDI-Device Identifier: 07290017912011
• UDI-Public: 07290017912011
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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
• Device Expiration Date: 01/01/2026
• Device Model Number: MA-1007-0600_US_CM
• Device Catalogue Number: MA-1007-0600_US_CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female