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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA II VALVE, SMALL, WITH BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 92856
Device Problem Mechanics Altered (2984)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 11/01/2018
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 fell and hit their head in (b)(6) 2018. Following that, the patient¿s hydrocephalus symptoms deteriorated, and the patient visited the hospital. After checking the valve with a stratavarius, it was identified that the pressure setting was changed. It was confirmed that the stratavarius could adjust the valve to all settings. In addition, the shunt system¿s patency was identified by contrast. Both the valve and peritoneal catheter was replaced. The distal end of the catheter was occluded. The patency of the valve was confirmed, but analysis of the valve was still requested.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported the valve was implanted over two years prior.
 
Manufacturer Narrative
The returned valve was patent. It met the requirements for siphon, reflux, valve flux, pressure-flow and preimplantation testing. The valve setting did not change during the testing. The instructions for use states, ¿mri systems of up to 3. 0 tesla may be used any time after implantation and will not damage the strata ii valve mechanism, but can change the performance level setting. The performance level setting should always be checked before and after mri exposure. ¿ the valve did not pass leak testing due to multiple cuts near the inlet connector. 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¿¿ there was proteinaceous debris observed on the interior and exterior of 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 handling. Introduction of contaminants could result in improper performance of the shunt system. Particulate matter that enters the shunt system may result in shunt occlusion¿¿ and ¿the system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris. ¿ all valves are 100% tested at the time of manufacture. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that after replacing the valve and peritoneal catheter, the progress of the patient was good. It was stated that a foreign body was formed at the end of the peritoneal catheter so it was probably the cause of the occlusion. However, because the patient fell down and the valve was hit strongly, analysis on whether the valve was broken was requested.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATA II VALVE, SMALL, WITH BIOGLIDE
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8201041
MDR Text Key131584160
Report Number2021898-2018-00591
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number92856
Device Catalogue Number92856
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2019
Was Device Evaluated by Manufacturer? Yes
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: 12/27/2018 Patient Sequence Number: 1
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