MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 15 A.CONTROL RESERVOIR; HYDROCEPHALUS VALVES

Model Number	FV433T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: on the basis of juristic requirements we have to get the personal request by the surgeon as a step of safeguard.Unfortunately we did not receive a consent.An official release is missing for the investigation of the product.For this reason, we returned the product for our discharge without examination.Result: we can exclude a defect at the time of release.The valves met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that there was an issue with fv433t -progav sys w/sa 15 a.Control reservoir according to the complainant, the valve was believed to be not adjustable.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV SYS W/SA 15 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12658545
• Report Number: 3004721439-2021-00695
• Device Sequence Number: 19953420
• Product Code: JXG
• UDI-Device Identifier: 04041906132453
• UDI-Public: 4041906132453
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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 Expiration Date: 01/31/2014
• Device Model Number: FV433T
• Device Catalogue Number: FV433T
• Device Lot Number: 20008755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 10/19/2021
• 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 Age: 55 YR