MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FV770T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a prosa shuntsystem (article unknown) was implanted during a procedure performed in 2015.According to the complainant, the prosa was not possible to adjust.The valve is still implanted at the time of report.Patient to be seen again in clinic on 6/3/24 no harm to patients reported.
Additional Manufacturer Narrative
No analysis possible at the time of the report due to a lack of information on the product.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected information - b1, d1, g4, and h1.Manufacturing site evaluation: no product received to date.No patient complications were reported as a result of the revision procedure.
Event or Problem Description
It was reported that a prosa® (part # fv770t) was implanted during a procedure performed in 2015.According to the complainant, the prosa valve was not able to be adjusted.The patient underwent a revision procedure in (b)(6) 2024; however, the exact date was not provided.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 19478397
• Report Number: 3004721439-2024-00157
• Device Sequence Number: 17161736
• Product Code: JXG
• UDI-Device Identifier: 04041906135553
• UDI-Public: 04041906135553
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: FV770T
• Device Catalogue Number: FV770T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown