MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 10 A.PRECHAMBER HYDROCEPHALUS VALVES

Model Number FV439T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Patient information: sex, weight, and height: unknown. Implant date: unknown. Explant date: unknown. When additional information is received, a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "after implanted for a period of time, the patient was checked back into the hospital for pressure adjustment. But it was found unable to adjust the pressure. The valve pressure data was maintained with the same as last time. The device was explanted. ".

• Brand Name: PROGAV SYS PED.W/SA 10 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS VALVES
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8111573
• MDR Text Key: 128629108
• Report Number: 3004721439-2018-00278
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2019
• Device Model Number: FV439T
• Device Catalogue Number: FV439T
• Device Lot Number: 20027089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 11/05/2018
• Device Age: 3 YR
• Event Location: No Information
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/28/2018 Patient Sequence Number: 1