MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number 46700

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the doctor discovered "the tube wall external drainage and monitoring system had its own cleft" during the implantation of the material.The product was replaced and the patient's status was alive-no injury.It was further clarified that the wall of the pipe of the external drainage and monitoring system had a rift.

Manufacturer Narrative

The returned device was patent.It did not meet the requirements for leak testing due to a crack observed at the zero point reference stopcock.It is unknown how or when this damage occurred.Proteinaceous debris was observed within the interior and exterior of the tubing.All edms devices are 100% leak tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the doctor discovered the rift in the wall of the pipe during the surgical implantation.The doctor promptly notified the distributor to replace the device so that the operation could be performed smoothly.There was no major impact to the patient.

• Brand Name: EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7610791
• MDR Text Key: 111828020
• Report Number: 2021898-2018-00295
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 00643169707665
• UDI-Public: 00643169707665
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Model Number: 46700
• Device Catalogue Number: 46700
• Device Lot Number: 214690877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2018
• 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 Age: 76 YR
• Patient Weight: 60