MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG MININAV SET PED.10 W/PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV680T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to miethke that a mininav (part # fv680t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the valve malfunctioned.The patient underwent a revision procedure on (b)(6) 2021.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: unknown height: unknown weight: unknown gender: male.
Event or Problem Description
No sample for investigation return to the manufacturer.No further informations were submitted.
Additional Manufacturer Narrative
Manufacturing site evaluation: no device was returned for investigation.Manufacturing and quality control data: the mininav was manufactured by a qualified employee in february 2021.Deviations during assembly did not occur.The shunt system was sterilized by miethke and released for shipment after final inspection.The mininav valve has a fixed pressure of 10 cmh2o.The valve was inspected as article fv680t.All parameters (opening pressure, reflux, leak-proof/integrity of housing, adjustability and brake function) have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Reason of complaint: "at the time of purging the valve, the doctor tells us that the liquid was going in both directions.He decided to place it anyway, and the next day he changed it, because it was still malfunctioning." result : an investigation was not possible because no sample was sent in for analysis.Based on our documentation of the product, we can exclude the presence of a defect at the time of delivery of the valve, as these documents show that the valve was delivered in perfect condition.The reason for the above-mentioned dysfunction is not clear to us.Without an investigation, we are unable to determine a valuation or a defect of the product.Based on the current information, no further regulatory actions are required from our point of view.

• Brand Name: MININAV SET PED.10 W/PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12134685
• Report Number: 3004721439-2021-00195
• Device Sequence Number: 4508843
• Product Code: JXG
• UDI-Device Identifier: 04041906133283
• UDI-Public: 4041906133283
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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 Expiration Date: 01/31/2026
• Device Model Number: FV680T
• Device Catalogue Number: FV680T
• Device Lot Number: 20051936
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 10/01/2021
• 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