MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 10 SYS W.PED.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX817T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue (part # fx817t) was implanted during a procedure performed on an unknown date.According to the complainant, the mblue10 shunt had inadvertently reprogrammed.In early (b)(6), the valve was adjusted to eight (8).When the patient returned on (b)(6) 2021, the valve verified at 16 (sixteen).The valve was adjusted back to eight (8) and the setting was verified with both compasses.On (b)(6) 2022 the patient returned for follow-up and the valve setting remained at eight (8), which was the prior setting.No further adjustments were made during this visit.The patient was scheduled to undergo a computed tomography (ct) scan and shuntogram.The complaint device is still implanted and not yet available for further evaluation.The patient is scheduled for clinical follow-up.
Additional Manufacturer Narrative
Manufacturing site evaluation: the device remains implanted, therefore, it is not available to be returned to the manufacturer for physical evaluation.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 the serial number was not 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 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, and may be a possible cause for the reported issue.

• Brand Name: M.BLUE 10 SYS W.PED.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 15066821
• Report Number: 2916714-2022-00070
• Device Sequence Number: 17525255
• Product Code: JXG
• UDI-Device Identifier: 04041906504533
• UDI-Public: 4041906504533
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2022
• Report Date (Section F): 07/20/2022

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 Expiration Date: 08/12/2025
• Device Model Number: FX817T
• Device Catalogue Number: FX817T
• Device Lot Number: 20049348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2022
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2022
• 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: 07/20/2022