MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	FX471T
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a progav 2.0 sys ped.W/sa20 a.Burrhole res (part# fx471t) was implanted on an unspecified date.According to the complainant the device was not keeping pressure settings.Every time the patient came in to the clinic the pressure was different than when he left clinic previously.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Visual inspection: during the investigation, discoloration, but no deformation of the outer housing or other visible defects was determined.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test to investigate the valve the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal position.The results show that the valve is not operating within the acceptable tolerance in the horizontal position.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valve, no deposits were found in.Result: based on our investigation results, we cannot determine functional deviations or other abnormalities in the progav 2.0.How the abovementioned functional impairment occurred is not clear to us at the time of examination.The examination of the return has been completed with the drafting of this report.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 20976547
• Report Number: 2916714-2024-00206
• Device Sequence Number: 12873443
• Product Code: JXG
• UDI-Device Identifier: 04041906138165
• UDI-Public: (01)04041906138165(11)200305(17)250223(10)20046458
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025
• Report Date (Section F): 12/19/2024

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 Expiration Date: 02/23/2025
• Device Model Number: FX471T
• Device Catalogue Number: FX471T
• Device Lot Number: 20046458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2024
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 02/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 12/19/2024