MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA WITH PROGAV 2.0; HYDROCEPHALUS MANAGEMENT

Model Number	FX992T
Medical Device Problem Codes	Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Hydrocephalus (3272)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Aesculap inc.(importer) is submitting this report on behalf of christoph miethke gmbh & co.Kg (manufacturer).Exemption number: e2017044.Manufacturing site evaluation: evaluation on-going.
Event or Problem Description
Country of complaint: (b)(6).It was reported that the valve is not adjustable.
Additional Manufacturer Narrative
Due to the missing release for evaluation, it could be checked only the tracebility data of the product.No deviation could be detected.Therefore, the reason for the malfunction cannot be determined.
Event or Problem Description
A comprehensive review of the open complaints in the system was performed.Although this event was properly assessed and reported, the follow-up was not submitted.Therefore, the results of the investigation will be submitted subsequently.

• Brand Name: PROSA WITH PROGAV 2.0
• 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,, MO 14469 ; GM 14469
• MDR Report Key: 7084745
• Report Number: 3004721439-2017-00003
• Device Sequence Number: 13791043
• Product Code: JXG
• UDI-Device Identifier: 04041906138431
• UDI-Public: 4041906138431
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 06/30/2020
• Device Model Number: FX992T
• Device Catalogue Number: FX992T
• Device Lot Number: 20028141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2015
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 9 YR
• Patient Sex: Unknown