MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV WITH SHUNTASSISTANT 10; HYDROCEPHALUS MANAGEMENT

Model Number	FV447T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product for investigation has not yet reached us.When additional informations are provided, a follow up will be submitted.
Event or Problem Description
It was reported that there was a problem with a progav shuntsystem.The pressure could not be adjusted.The patient was without harm, but a surgical intervention was conducted.A new progav was replaced and implanted.Additional informations will be provided in a follow up.
Additional Manufacturer Narrative
New informations was received from thr affiliate on 10/28/2020.Because of a mixed up from the surgeon, this case was not with correct description and problem.Another new case will be raised instead of this one for correct serial#.Mdr #3004721439-2020-00240.The manufacturer was requested to cancel the case.
Event or Problem Description
New informations are available, update in h10/h11.

• Brand Name: PROGAV WITH SHUNTASSISTANT 10
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10743684
• Report Number: 3004721439-2020-00233
• Device Sequence Number: 3312547
• Product Code: JXG
• UDI-Device Identifier: 04041906132675
• UDI-Public: 4041906132675
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: 10/22/2019
• Device Model Number: FV447T
• Device Catalogue Number: FV447T
• Device Lot Number: 20024942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/02/2020
• 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