MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX991T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a prosa was not adjustable postoperatively.The valve was implanted on (b)(6) 2015.It was removed on (b)(6) 2017 due to the malfunction and returned to the manufacturer.Further details were not provided.Height: 170 cm.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: ( description incoming product condition) the valve was returned submersed in an unidentified liquid in the provided returnkit.Result: first we performed a visual inspection of the valve.Except for scratches, no significant deformations or damage of the valve were detected.The measurement of the plane parallelism could confirm this.Next we tested the permeability, adjustability, brake functionality and brake force.The valve operates as expected and met all specifications.Finally, we dismantled the valve.Inside the valve we have found a minimal build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of non-adjustability.At the time of our investigation, the valve was able to be adjusted to all specified settings.We cannot explain why adjustment difficulties could occur in the past.We can only assume that the implantation region may have been selected unfavorably due to the anatomical conditions of the patient, or that the deposits found could have temporarily impaired the valve.As described in scientific literature, the deposits encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miehtke (b)(4).No further actions required.

• Brand Name: PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV.
• 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: 12954428
• Report Number: 3004721439-2021-00800
• Device Sequence Number: 4292377
• Product Code: JXG
• UDI-Device Identifier: 04041906138493
• UDI-Public: 4041906138493
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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: FX991T
• Device Catalogue Number: FX991T
• Device Lot Number: 20027364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 48 YR
• Patient Sex: Unknown
• Patient Weight: 80 KG