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 Code	Implant Pain (4561)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dr.(b)(6) has assured the patient that it is part of the healing process.Patient will update dr.(b)(6) of any changes.Patient reports no more pain after being prescribed meds by hcp, the implant activation is scheduled for (b)(6).
Event or Problem Description
Patient called and reported sharp burning pain in ankle near incision site.She said the pain started last night, (b)(6) 2025 around 9:30pm and she took her sleeping pills that helped her go to bed.Pain woke her up at 3am and she had to take otc pain medication to go back to bed.She describes the pain to be an 8 out of 10 when present.Today the pain has been off and on and not triggered by any certain activity.She did have an appt with dr.(b)(6) and she said the incision looks good and not sure what may be causing pain.She was prescribed gabapentin for pain which she will take today.She was implanted on (b)(6) and yet to be activated.(b)(6) advised patient to follow dr.(b)(6) instructions of resting, elevating leg and taking prescribed medication of gabapentin.

• 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: 22869143
• Report Number: 3012239564-2025-00012
• Device Sequence Number: 21056422
• 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: 2025
• 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): 08/21/2025

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
• Device Lot Number: 2401101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/21/2025
• 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 Sex: Female