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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42866
Device Problem Mechanics Altered (2984)
Patient Problems Fatigue (1849); Headache (1880)
Event Date 04/12/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient underwent insertion of the shunt on (b)(6) 2019. The patient presented in the emergency department 3 days after discharge with drowsiness and severe headache due to spontaneous change of valve setting. They were admitted, and on continuous monitoring, it was confirmed that the valve was malfunctioning. It was spontaneously changing its setting. The device was explanted and replaced.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that there were no environmental/external/patient factors that may have led or contributed to the issue.
 
Manufacturer Narrative
The performance level (pl) of the returned product could not be adjusted from 1. 0 prior to or after flushing the valve. Therefore, valve flux, siphon, patency, leak, reflux, pressure/flow and preimplantation testing could not be performed. Therefore, the nature of the complaint could not be replicated by laboratory personnel. Proteinaceous and crystalline debris was observed in the valve. The instructions for use cautions, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handing. Introduction of contaminants could result in improper performance of the shunt system ¿ shunt obstruction may occur in any of the components of the shunt system. The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris. ¿ tears were observed on the reservoir and on the proximal occluder. It is unknown how or when this damage occurred. The instructions for use cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components. Such damage may lead to loss of shunt integrity¿¿ all valves are 100% tested at the time of manufacture. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATA II VALVE, REGULAR
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer Contact
katcha taylor
9775 toledo way
irvine,ca, MN 92618
7635263305
MDR Report Key8600258
MDR Text Key144719699
Report Number2021898-2019-00180
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodePK
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model Number42866
Device Catalogue Number42866
Device Lot NumberE53096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2018
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: 05/10/2019 Patient Sequence Number: 1
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