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

Model Number	46700
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient underwent cerebrospinal drainage surgery.During the procedure, it was found that the device ¿easily fell off near the effusion chamber.¿ the device was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
Patient weight updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported physiological saline was used to clean the stopcock connections prior to use.
Additional Manufacturer Narrative
The returned device was patent.It did not meet the requirements for leak testing due to a disconnection observed at the main system stopcock between the patient line tubing and luer lock connector.It is unknown how or when this damage occurred.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.

• Brand Name: EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7061957
• Report Number: 2021898-2017-00596
• Device Sequence Number: 2037314
• Product Code: GWM
• UDI-Device Identifier: 00643169707665
• UDI-Public: 00643169707665
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983799
• 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,Followup
• Report Date (Section B): 03/01/2018

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: 08/31/2021
• Device Model Number: 46700
• Device Catalogue Number: 46700
• Device Lot Number: 211990166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2017
• Supplement Date Received by Manufacturer: 11/30/2017; 02/21/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/29/2017; 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 69