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	Coma (2417); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
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 was leaking at one of the stopcocks.It was stated that it was unknown if there were any patient symptoms or complications associated with the event.The patient¿s medical history included trauma.The patient outcome was listed as alive ¿ with injury; they were currently in a coma.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional review indicated that the device was replaced due to the leaking.
Additional Manufacturer Narrative
The returned product was patent and met the requirements for leak testing.Therefore the conditions of this complaint could not be duplicated by laboratory personnel.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.
Event or Problem Description
Additional information received reported the patient being unconscious was not related to the device.This was due to the patient¿s history of trauma.It was stated the leaking occurred at the main system stopcock.

• 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: 7480801
• Report Number: 2021898-2018-00230
• Device Sequence Number: 195988
• 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,Followup
• Report Date (Section B): 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2022
• Device Model Number: 46700
• Device Catalogue Number: 46700
• Device Lot Number: 214690877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018; 05/22/2018; 05/16/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 05/02/2018; 05/24/2018; 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 69 YR
• Patient Weight: 65