MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG BURR HOLE RESERVOIR PED; HYDROCEPHALUS MANAGEMENT

Model Number	FV039T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a burr hole reservoir (#fv039t) was implanted during a procedure performed on (b)(6) 2018.According to the complainant, the reservoir caused an underdrainage in combination with a progav 2.0 shuntsystem.The patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 5 years, 8 months, height: 105 centimeters (cm), weight: 17 kilograms (kg), gender: male.Same incident as medwatch# 3004721439-2023-00234.
Additional Manufacturer Narrative
No sample available.The manufacturing data were recorded and checked.No deviation could be determined.

• Brand Name: BURR HOLE RESERVOIR PED
• 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, 14469 ; GM 14469
• MDR Report Key: 17541113
• Report Number: 3004721439-2023-00235
• Device Sequence Number: 17734899
• Product Code: JXG
• UDI-Device Identifier: 04041906116408
• UDI-Public: 4041906116408
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2022
• Device Model Number: FV039T
• Device Catalogue Number: FV039T
• Device Lot Number: 20034697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2017
• 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: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 17 KG