MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 25; HYDROCEPHALUS MANAGEMENT

Model Number FX414T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that a valve cannot be adjusted.The reporter indicated that a 27-day post-operative valve cannot be adjusted.The device was explanted.Patient information and additional event details have not provided, however, have been requested.

Manufacturer Narrative

Result: an investigation was not possible because no product was sent for investigation.With reference to the complaint of non-adjustment of the valve and over-drainage, we assume that that any deposits of protein have been affected the function of the valve.Referring to the reason complaint of the no adjustable we point out that it is important to position the adjustment tool centrally over the valve.Another explanation for this may be that the implantation position has been chosen unfavorably due to the anatomical conditions of the patient, or that the skin over the valve was too thick, which could have caused adjustment difficulties.As described in our literature, any deposits can also impair the function of the valves.However, we cannot finally clarify what influenced the function, as this would require an examination of the valve.Further actions based on the current information, no further actions are required from our point of view.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 25
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9733756
• MDR Text Key: 188544701
• Report Number: 3004721439-2020-00044
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX414T
• Device Catalogue Number: FX414T
• Device Lot Number: 20043609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention