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

Model Number	46700
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
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 that during the drainage of the patient, the cerebrospinal fluid was blocked in the chamber and could not flow into the drainage bag.The product was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported it was unknown if there were any external/environmental/patient factors that may have led or contributed to the issue.
Additional Manufacturer Narrative
The returned product was patent.The product did not meet the requirements for leak test due to an occlusion in the chamber outlet possibly due to excess adhesive.Proteinaceous debris was observed on the interior of the edms in the patient line.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: 8171522
• Report Number: 2021898-2018-00569
• Device Sequence Number: 1961047
• 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): 02/19/2019

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: 04/29/2023
• Device Model Number: 46700
• Device Catalogue Number: 46700
• Device Lot Number: 215518496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 12/27/2018; 01/25/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/07/2019; 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 58