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

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

An investigation was not possible because the product is still implanted.Due to missing information (patient data, serial number, device itself), it is unable to provide a meaningful analysis.Based on the information provided, no patient injury due to a malfunction of the shunt is reported.The valve is still implanted and the patient is stabil.

Event Description

It was reported that a progav 2.0 was implanted during a procedure performed at memorial sloane kettering on (b)(6) 202.According to the complainant, the valve was unable to adjust from 5 to 10 cmh2o.The patient to be seen in clinic for follow up.The device is still implanted and the patient is stable.

• Brand Name: PROGAV 2.0
• 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: 18955412
• MDR Text Key: 338994186
• Report Number: 3004721439-2024-00064
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 03/01/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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