MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number	FV251T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Pressure Problem (3012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation results: the basis of juristic requirements we have to get the personal request by the surgeon as a step of safeguard.Unfortunately we did not receive a consent.An official release is missing for the investigation of the product.For this reason, we returned the product for our discharge without examination.Results: 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.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that there was an issue with fv251t- shuntassistant 20.According to the complaint description, the customer asks for verification of the correct opening pressure.Additional information was not available.

• Brand Name: SHUNTASSISTANT 20
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12410428
• Report Number: 3004721439-2021-00619
• Device Sequence Number: 17238767
• Product Code: JXG
• UDI-Device Identifier: 04041906113209
• UDI-Public: 4041906113209
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 09/01/2021

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 Model Number: FV251T
• Device Catalogue Number: FV251T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2016
• Initial Report FDA Received Date: 09/01/2021
• 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