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

Catalog Number	46913
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/20/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All edms devices are 100% leak tested at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that there was an error turning off the stopcock to the device between the transducer stopcock and the drip chamber.According to the report, the prior similar equipment manufactured by another manufacturer had the "on/off" stopcock manipulation for monitoring in the exact opposite direction from the reported device.Inconsistency in design between those devices was a contributing factor to the use error.Reportedly, the patient died on (b)(6) 2017.The original intended procedure was for intracranial fluid drainage.

• Brand Name: DUET 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: 6786585
• Report Number: 2021898-2017-00437
• Device Sequence Number: 1361097
• Product Code: GWM
• UDI-Device Identifier: 00613994445360
• UDI-Public: 00613994445360
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

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: 07/31/2018
• Device Catalogue Number: 46913
• Device Lot Number: 209909471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/10/2017
• 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: Death
• Patient Age: 57 YR
• Patient Weight: 56