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 Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peripheral Edema (4578)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient selection was inappropriate.Patient with cp and motor difficulties + implantation area deformed/scarred due to previous surgeries (bilaterally) no signs of infection or harm caused by the implant itself.
Event or Problem Description
Pre-explant leg evaluation - mild edema distal to the implantation location.Scar looks clean.No erythema or pain upon palpation, scarring tissue is evident from previous surgeries on the leg.Explantation summary: implant found at 4mm depth - capsule incised sharply and sutures removed.Clear fluid was noticed in the capsule and sampled for c&s (waiting for results) conclusion (agreed with hcp): patient selection was inappropriate.Patient with cp and motor difficulties + implantation area deformed/scarred due to previous surgeries (bilaterally) no signs of infection or harm caused by the implant itself.

• 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: roni diaz ; 6 maskit street; herzliya, tel aviv 46140-0 ; IS 461400
• MDR Report Key: 20559891
• Report Number: 3012239564-2024-00002
• Device Sequence Number: 13010844
• Product Code: QXM
• UDI-Device Identifier: 07290017912011
• UDI-Public: 07290017912011
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K240037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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: 08/01/2024
• Device Model Number: MA-1007-0600_US_CM
• Device Catalogue Number: MA-1007-0600_US_CM
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/29/2024
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White