MAUDE Adverse Event Report: SOPHYSA SOPHYSA; PRESSIO® ICP MONITORING KIT, VENTRICULAR TUNNELING

Model Number	PSO-VT
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned to manufacturer on 03/18/2022.Aspect control : device was sent in dry conditions, relatively clean.A slight tear was noticed on capsule-protective membrane.Black color on the micro wires indication of an oxidation.No sign of any other visible damage.Functional control : error e001 is confirmed to occur upon connecting the device to a monitor.Further examination of the device proves the oxydation of the electrical wires iin the device which caused the anomaly.
Event or Problem Description
Device implanted on (b)(6) 2022.The same day, four hours after initial surgery, the monitor displayed error e001.The monitoring couldn't be maintained so the device was explanted.There were no health complications for the patient.

• Brand Name: SOPHYSA
• Common Device Name: PRESSIO® ICP MONITORING KIT, VENTRICULAR TUNNELING
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquêt; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYA; temis; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: marion prudhomme ; temis; rue sophie germain; besançon, 25000 ; FR 25000
• MDR Report Key: 13939220
• Report Number: 3001587388-2022-22107
• Device Sequence Number: 6702253
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: (01)03760124131482(11)201106(17)251101
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Model Number: PSO-VT
• Device Catalogue Number: PSO-VT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (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: 56 YR
• Patient Sex: Male