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

Model Number	46700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2018
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 the 3 way adapter leaked and couldn't be tightened.It was noted that the patient's status at the time of the report was alive-no injury.
Additional 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.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.
Additional Manufacturer Narrative
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: 7767811
• Report Number: 2021898-2018-00393
• Device Sequence Number: 11110732
• Product Code: GWM
• UDI-Device Identifier: 00643169707665
• UDI-Public: 00643169707665
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 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: 11/14/2022
• Device Model Number: 46700
• Device Catalogue Number: 46700
• Device Lot Number: 214570967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/31/2018; 08/08/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/19/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1