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	Defective Device (2588)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced electrical shocks when using the device.
Additional Manufacturer Narrative
Bluewind has adopted more stringent reporting criteria for implant-related complaints starting (b)(6) 2026.A retrospective review of two years of complaint data, covering the period from (b)(6) 2024 to (b)(6) 2026, was performed.A total of 543 patient cases were reevaluated.Of these, 68 cases involved patient infection, pain, wound healing issues, implant failure, or surgical complications.These 68 cases were reassessed against the updated reporting criteria for implant-related complaints, and four complaints were determined to be reportable under the new criteria.Complaint (b)(4) is one of four reportable cases.

• Brand Name: REVI SYSTEM
• Common Device Name: IMPLANTED TIBIAL ELECTRICAL URINARY, PRODUCT CODE: QXM
• Manufacturer (Section D): BLUEWIND MEDICAL LTD; 6 maskit st. bussiness park; building b pob 4101; herziliya, 46140 02; IS 4614002
• Manufacturer (Section G): BLUEWIND MEDICAL LTD; 6 maskit street.; p.o. box 4100 herzliya 461402,; herziliya, ; IS
• Manufacturer Contact: angel estrada ; 1389 center drive suite 200; park city, ut 84098, usa; park city, UT ; 7742842463
• MDR Report Key: 25202088
• Report Number: 3012239564-2026-00024
• Device Sequence Number: 10010035
• Product Code: QXM
• UDI-Device Identifier: 07290017912011
• UDI-Public: 07290017912011
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: 04/01/2023
• 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: 07/03/2024
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female