MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASSISTANT 20; HYDROCEPHALUS SHUNT

Model Number FX417T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Headache (1880)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).Under-drainage was caused, therefore, the products were removed and competitor's product was implanted as the replacement.Primary surgery was done (b)(6) 2017 with 10cmh2o.On (b)(6) 2017, slit was caused and value changed to 18cmh2o.The patient condition had been stable for about two months after the value change.On (b)(6) 2017, ventricular enlargement and headache were caused and the value changed to 10cmh2o again.On (b)(6) 2017, the slit was caused again.The value changed to 18cmh2o and 14cmh2o due to headache.However, the patient condition improvement was not seen.All medwatch submissions related to this report are: 3004721439-2017-00018, and 3004721439-2017-00020.

Manufacturer Narrative

Investigation results: visual investigation of the received shunt assistant indicated no deformations present, although there were some scratches present.Permeability testing was conducted at hydrostatic pressure difference of approximately 20-30 cmh20 in the flow direction.The valve was found to be permeable.Adjustment testing is not applicable, this valve has a fixed pressure setting.Brake force and brake function testing is not applicable, this valve has no brake.The valve was tested using computer controlled testing apparatus.The valve was tested by simulating liquid flow between 60 ml/h down to 5 ml/h and up again to 60 ml/h in a vertical position (per iso 7197).Test results indicate the valve has overdrainage, not underdrainage as the complaint reported.The valve was opened to investigate the possibility of the presence of natural cerebrospinal substances (protein, blood or tissue particles).Deposits were present.No action is required, the reported issue is a known and unchanging risk of hydrocephalus therapy with shunt implants.

Event Description

Additional information related to original report: 3004721439-2017-00018 - reported to document the 28aug2017 valve setting change.3004721439-2017-00019 - reported to document the 25oct2017 valve setting change.3004721439-2017-00020 - reported to document the (b)(6) 2017 revision surgery.

• Brand Name: SHUNTASSISTANT 20
• Type of Device: HYDROCEPHALUS SHUNT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, D-144 69; GM D-14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, D-144 69; GM D-14469
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7119470
• MDR Text Key: 95755393
• Report Number: 3004721439-2017-00019
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2022
• Device Model Number: FX417T
• Device Catalogue Number: FX417T
• Device Lot Number: 20033166
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/13/2017
• Device Age: 8 MO
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Weight: 44