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	Hydrocephalus (3272)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the still implanted sample, we are unable to provide a meaningful investigation.According to the complaint description, it is not possible to clear the cause of the adjustment difficulties.Deposits might be a possible cause.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.However, a meaningful result requires a complete examination of the sample.From our point of view, no further regulatory actions are required.
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 june, 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 t was 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.

• 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
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 15066852
• Report Number: 3004721439-2022-00202
• Device Sequence Number: 5504226
• Product Code: JXG
• UDI-Device Identifier: 04041906504533
• UDI-Public: 4041906504533
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Labeled for Single Use? (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
• Patient Sex: Unknown