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	Implant Pain (4561)
Date of Event	12/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was experiencing severe pain at the implant site and requested explantation of the device.The patient was also diagnosed with severe venous insufficiency and was likely not an ideal candidate for revi.
Additional Manufacturer Narrative
Bluewind has adopted more stringent reporting criteria for implant-related complaints starting april 24, 2026.A retrospective review of two years of complaint data, covering the period from march 1, 2024 to march 1, 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 00514 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 street; 1389 center drive suite; park city, ut 84098, usa
• 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: 25200928
• Report Number: 3012239564-2026-00021
• Device Sequence Number: 10019240
• Product Code: QXM
• UDI-Device Identifier: 07290017912011
• UDI-Public: 07290017912011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/12/2026

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 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: 12/29/2025
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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
• Patient Age: 88 YR
• Patient Sex: Female