MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY BECKER EDMS II, EURO, GREEN PATIENT LINE; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number 27702

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the device detached at the drainage tap where the cerebrospinal fluid drips into the bag.The device could not be reassembled.The physician replaced the device with another one, and the issue was resolved.The patient was fine, but a new device had to be opened up and switched over.

Manufacturer Narrative

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

• Brand Name: BECKER EDMS II, EURO, GREEN PATIENT LINE
• 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: 7719995
• MDR Text Key: 115373723
• Report Number: 2021898-2018-00370
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 00721902495687
• UDI-Public: 00721902495687
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K984053
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2023
• Device Model Number: 27702
• Device Catalogue Number: 27702
• Device Lot Number: 214994590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 03/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1