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

Model Number FV434T

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the valve does not program.The reporter indicated that a post operative progav sys w/sa 20 a.Control reservoir was implanted in the patient on (b)(6) 2019, however, the valve does not program and the patient required a re-operation.Additional details of the event are not available.

Manufacturer Narrative

Investigation optical inspection not applicable, because no products were available for examination.Permeability test not applicable, because no products were available for examination.Adjustment test not applicable, because no products were available for examination.Braking force and brake function test not applicable, because no products were available for examination.Result an investigation was not possible because no product was send for investigation.We point out that it is important to position the adjustment tool centrally over the valve.Please keep in mind, that despite of a correct use of the adjustment tool it may can be difficult to adjust the valve due to a postoperative swelling of the skin within the first few days.In addition, as described in our literature, any deposits of protein or blood that may be present can as well affect the functioning of the valve.What actually has led to the difficulties in adjusting, does not explain to us, since this would require an investigation of the product.Further actions based on the current information, no further actions are required from our point of view.

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8996488
• MDR Text Key: 161221816
• Report Number: 3004721439-2019-00240
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: FV434T
• Device Catalogue Number: FV434T
• Device Lot Number: 20032833
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention