MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FX431-T

Device Problem Complete Blockage (1094)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

Additional information / investigation results will be provided in a supplemental report, if available.

Event Description

It was reported that there was a problem with a progav 2.0 shunt system.In (b)(6) 2019, the patient was implanted with fx431-tand fv251t.In (b)(6) 2020, the patient was admitted to the hospital for reexamination.It was found that there was no fluid outflow from the abdominal end, so it was difficult to press the fluid reservoir.Patient information: age: unknown.Weight: unknown.Hight: unknown.Gender: unknown.Implantation: (b)(6) 2019 related mdr number 3004721439-2020-00148, because same patient.

Event Description

Additional information was available, upon receipt of the device.Patient information: age: 52 years.Weight: 70 kg.Hight: 168 cm.Explantation: (b)(6) 2020.Related mdr number 3004721439-2020-00148, because same patient.

• Brand Name: PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10369043
• MDR Text Key: 207553240
• Report Number: 3004721439-2020-00147
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2022
• Device Model Number: FX431-T
• Device Catalogue Number: FX431-T
• Device Lot Number: 20035745
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 70