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

Model Number	MA-1007-0600_US_CM
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called to report for the past few weeks when she initiates treatment, she gets a "bolt of pain", sufficiently uncomfortable she has stopped using the device.The problem began about six weeks ago; she could not think of any change or event that might have precipitated the problem.Ps advised her to stop using the wearable while the bluewind medical investigate.
Additional Manufacturer Narrative
Bluewind medical is providing this report in compliance with fda 21cfr part 803.Patient feeling pain may be caused due to the implant functionality failure.As a result, a design history record review was performed to confirm the sterility of the implant.Similar failures from the past were reviewed and patient is being offered a free replacement-the initial request was sent to the hcp.

• 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: 22542664
• Report Number: 3012239564-2025-00003
• Device Sequence Number: 20947044
• Product Code: QXM
• UDI-Device Identifier: 07290017912011
• UDI-Public: 07290017912011
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: Health Professional
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White