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

Model Number	FV434T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: the valve was manufactured and inspected by a qualified employee in march 2007.Deviations during assembly did not occur.All parameters were inspected and approved during manufacturing, and met specifications.Statement: 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 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 valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further actions required.
Event or Problem Description
According to the complainant a progav was not adjustable postoperatively.The patient was originally implanted in 2008.The explant date was on (b)(6) 2016.The valve was returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12463632
• Report Number: 3004721439-2021-00626
• Device Sequence Number: 1244659
• Product Code: JXG
• UDI-Device Identifier: 04041906132460
• UDI-Public: 4041906132460
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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 Model Number: FV434T
• Device Catalogue Number: FV434T
• Device Lot Number: 20006125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2016
• Initial Report FDA Received Date: 09/13/2021
• 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: 54 YR
• Patient Weight: 79