MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES; HYDROCEPHALUS MANAGEMENT

Model Number FX448T

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that shunt blockage occurred.Patient information was not provided.Additional information has been requested.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9583732
• MDR Text Key: 188558397
• Report Number: 3004721439-2020-00011
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX448T
• Device Catalogue Number: FX448T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other