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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STRATA SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 27819
Device Problem Insufficient Information (3190)
Patient Problems Fatigue (1849); Coma (2417)
Event Date 06/01/2021
Event Type  Injury  
Manufacturer Narrative
Patient weight not available from the site. Device lot number, serial number and unique identifier was unavailable. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2013 the patient was implanted with a medtronic adjustable pressure shunt due to hydrocephalus. The patient underwent mri examinations after the surgery 3 times and there was no pressure adjustment after the examination. On (b)(6) 2021 the patient began to show symptoms of drowsiness. The patient suddenly went into a coma, and the patient's family member sent the patient to the hospital. The patient is currently hospitalized in the emergency department and is still in a coma. The site is requesting that the patient needs to undergo a vascular mri examination. The site would like a medtronic representative to go to the site and measure the pressure before and after the mri examination for the patient.
 
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Brand NameSTRATA
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12213272
MDR Text Key263432830
Report Number2021898-2021-00140
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number27819
Device Catalogue Number27819
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/22/2021 Patient Sequence Number: 1
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