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

Model Number	27702
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: BECKER EDMS II, EURO, GREEN PATIENT LINE
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7719995
• Report Number: 2021898-2018-00370
• Device Sequence Number: 1588119
• Product Code: GWM
• UDI-Device Identifier: 00721902495687
• UDI-Public: 00721902495687
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K984053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1