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

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported that a miethke shunt (#article unknown) was implanted during a procedure.According to the complainant, the miethke shunt was believed to be operated in underdrainage and adjustment difficulties.The patient underwent a revision procedure.No patient complications were reported as a result of the revision procedure.The complainant device was returned to the manufacturer for evaluation.Age: 38 years height: 185 cm weight: 87 kg gender: male no further data available at the time of the report.

Manufacturer Narrative

Due to the missing product information (e.G.Serial number/delivery note batch), we were unable to trace the production of affected product.We can assure you that all our products are manufactured by qualified staff and individually tested before they are placed on the market.An investigation was not possible because the product is not available.Regarding similar complaints where we could examine the products, we could determine that the most frequent cause for a deterioration in the function of the product are deposits caused by natural substances in the cerebrospinal fluid, e.G.Protein, blood or tissue particles.These are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve if aggregated in the valve.A final clarification of the cause what has led to malfunction is only possible by an examination.Due to missing information (serial number, device itself), we are unable to provide a meaningful analysis.A final conclusion on the suspected malfunction is only possible with an examination.

Event Description

The device was not returned for investigation.No data of the article number or the seriel number are submitted.

• Brand Name: SHUNT
• Type of Device: 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: 18425609
• MDR Text Key: 331859284
• Report Number: 3004721439-2023-00394
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 87 KG