MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 15 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV440T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer investigation: the device serial number was not provided, therefore, a review of the manufacturing records was not able to be performed.Additionally, the product was not returned to the manufacturer for evaluation.Progav devices have a normal pressure range of 0 to 20 centimetres of water (cm h2o) and the shuntassistant has a fixed pressure from 15 cm h2o.During manufacturing, all parameters, including opening pressure, reflux, adjustability and brake function, are inspected to ensure that each device meets specification.The shunt system was inspected as article fv440-t.A visual examination of the complaint device was not able to be performed as no parts were received for analysis.Therefore, the complaint was not able to be confirmed.However, a known inherent risk of hydrocephalus therapy using implantable shunts is the buildup of protein deposits inhibiting the proper functionality of the valve.Without examination of the complaint device, the root cause cannot be determined.
Event or Problem Description
The complainant reported that the liquid storage capsule springs back well and the valve pressure was not able to be adjusted.The patient was resuscitated after several episodes of fainting.The shunt had been implanted for seven (7) years and pressure adjustments were performed according to the patient's condition.No further information has been made available.

• Brand Name: PROGAV SYS PED.W/SA 15 A.PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10511298
• Report Number: 3004721439-2020-00190
• Device Sequence Number: 16927511
• Product Code: JXG
• UDI-Device Identifier: 04041906132538
• UDI-Public: 4041906132538
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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 Model Number: FV440T
• Device Catalogue Number: FV440T
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 09/09/2020
• 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