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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO DUET®; DEVICE, MONITORING, INTRACRANIAL PRESSURE

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MEDTRONIC MEXICO DUET®; DEVICE, MONITORING, INTRACRANIAL PRESSURE Back to Search Results
Model Number 46914
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2023
Event Type  malfunction  
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Medtronic received information regarding an external drainage and monitoring system (edms).It was reported that cerebrospinal fluid (csf) leakage was noted from the stopcock connected to the edms.Increased leakage was noted when the stopcock was clamped toward the patient or toward the chamber.The doctor was notified, and the equipment was changed out.No other drainage noted.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
DUET®
Type of Device
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX   22570
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key19046595
MDR Text Key340114400
Report Number9612164-2024-01609
Device Sequence Number1
Product Code GWM
UDI-Device Identifier00763000624774
UDI-Public00763000624774
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983799
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Risk Manager
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 04/22/2024
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
Device Operator Health Professional
Device Model Number46914
Device Catalogue Number46914
Device Lot Number226517897
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/03/2024
Initial Date FDA Received04/04/2024
Supplement Dates Manufacturer Received04/03/2024
04/12/2024
Supplement Dates FDA Received04/05/2024
04/22/2024
Date Device Manufactured05/09/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1163-2024
Patient Sequence Number1
Patient Age60 YR
Patient SexMale
Patient Weight90 KG
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