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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 27815
Device Problems Complete Blockage (1094); Infusion or Flow Problem (2964)
Patient Problems Pain (1994); Obstruction/Occlusion (2422)
Event Date 01/01/2014
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received regarding a patient implanted with a strata valve in 2014. It was stated that, for 3 months after implant, the device did not function at all. To the patient this suggested that it was plugged most likely with brain matter from the time of operation. An appointment was made with their physician and one week prior to meeting the pressure in the patient's head built enough that it "finally blew" and felt like a garden hose spraying in their abdomen. The physician decided it was okay at the time, and the patient noted that they feel if the device was plugged the debris has passed at this time. It was inquired if there were locations an x-ray could be done to determine if debris is in the valve.
 
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Brand NameSTRATA II SHUNT ASSEMBLY, REGULAR
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 Key11446956
MDR Text Key241575504
Report Number2021898-2021-00060
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number27815
Device Catalogue Number27815
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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