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

Model Number FX991T

Device Problem Environmental Compatibility Problem (2929)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported that 2y 5m po infection.The explanted product were delivered to miethke in dry and bloody state.The file is entered with limited information.An infection of the patient was the reason for the revision surgery.Height:175cm.

Manufacturer Narrative

Visual inspection not performed.Permeability test not performed.Adjustment test not performed.Braking force and brake function test not performed.Results the shunt system was submitted dry and with significant bloody residue.Due to the condition, the shunt system was received in and the noted risk of infection, we have determined that the risk level of this specimen is too great to allow for inspection by our employees.For this reason, the specimen has not been inspected and has been returned to the submitting hospital.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV.
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8407854
• MDR Text Key: 138379866
• Report Number: 3004721439-2019-00070
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX991T
• Device Catalogue Number: FX991T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2019
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 130