MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS SYS W/SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX834T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.However, deposits in the valve could be responsible for the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.
Event or Problem Description
It was reported that a m.Blue plus (part # fx834t) was implanted during a procedure performed on an unknown date.According to the complainant, the patient underwent a shunt replacement procedure on (b)(6) 2022.Reportedly, the patient was experiencing "continued symptoms, headache, etc." the complaint device was not available to be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: M.BLUE PLUS SYS W/SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 15432762
• Report Number: 2916714-2022-00089
• Device Sequence Number: 6006008
• Product Code: JXG
• UDI-Device Identifier: 04041906504854
• UDI-Public: 4041906504854
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2022
• Report Date (Section F): 09/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX834T
• Device Catalogue Number: FX834T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/15/2022