MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 2.0 10; HYDROCEPHALUS MANAGEMENT

Model Number	FX100T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was a problem with a shuntassistant (b)(4).The surgeon suspected that the valve operated in overdrianage and the valve was replaced.Patient information: age: (b)(6) years, weight: unknown, height:unknown, gender: unknown.Date of implantation: (b)(6) 2020, date of removal: (b)(6) 2020."associated medwatches: 3004721439-2021-00005 , mdr # - same patient".
Event or Problem Description
Investigation is completed."associated medwatches: 3004721439-2021-00005, mdr#- same patient/event".
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: -no abnormalities are detected permeability test: the test showed that the shuntassistant 2.0 is permeable.Some particles are flushed out during the test.Computer control test: the computer controlled test has shown the opening pressure of the shuntassistant 2.0, at a reference flow rate of 20 ml/h in a vertical position, to be 11.97 cmh2o.This is within the specified tolerance of 10 cmh2o +4/-2 cmh2o.Internal inspection of product: in order to verify whether the investigated valve was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the valve.After dismantling of the valve, no deposits were found in the shuntassistant 2.0.Results: based on our investigation, we are not able to substantiate the clinical claim of "over-drainage".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.Our investigations could not identify a deviations.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

• Brand Name: SHUNTASSISTANT 2.0 10
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11230184
• Report Number: 3004721439-2021-00004
• Device Sequence Number: 3805867
• Product Code: JXG
• UDI-Device Identifier: 04041906501563
• UDI-Public: 4041906501563
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 05/04/2025
• Device Model Number: FX100T
• Device Catalogue Number: FX100T
• Device Lot Number: 20047652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/26/2021
• 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 Age: 78 YR