MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 20 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FV434-T

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Event Description

It was reported that a progav shuntsystem (#fv434-t) was not implanted during a procedure performed on unknown.According to the complainant, the shunt showed a adjustment problem bevor implated.The complainant device has not yet returned to the manufacturer for evaluation.No patient involvment.Age: unknown.Weight: unknown.Height: unknown.Gender: unknown.

Manufacturer Narrative

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

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• 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: 18066007
• MDR Text Key: 327293371
• Report Number: 3004721439-2023-00327
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906130862
• UDI-Public: 4041906130862
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103003
• 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
• Report Date: 11/03/2023

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
• Device Model Number: FV434-T
• Device Catalogue Number: FV434-T
• Device Lot Number: 20057035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention