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	Pain (1994)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient came into the office for a 6-month follow-up visit.She said that she has been experiencing pain down her foot below the incision site and that her heel is numb.She wants the implant removed.She is looking to schedule the implant removal for the middle of august.She also stated that she had a lot of difficulty with the wearable and that it would take her over an hour to complete a treatment because it consistently timed out.She stopped using it altogether over a month ago.
Additional Manufacturer Narrative
The patient had pain down her foot below the incision site, and her heel is numb and following timed out sessions of ecu, stopped the treatment.Patient is expecting to get the implant removed, but it hasn't been scheduled yet.

• 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: 22900883
• Report Number: 3012239564-2025-00013
• Device Sequence Number: 12766947
• 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: 2024
• 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): 08/26/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/26/2025
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White