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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA II SNAP SHUNT, SMALL SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 27816
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Hemorrhage, Subdural (1894)
Event Type  Injury  
Manufacturer Narrative
Implant date is an approximation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient was implanted in (b)(6) 2017. It was stated the patient later presented with bilateral subdural hemorrhages. The shunt was set to 1. 5, and when it was checked, it was found to be at 0. 5. The patient was admitted to the hospital on (b)(6) and a revision surgery to replace the valve was conducted the following day.
 
Manufacturer Narrative
The returned valve was patent. All performance levels could be set with a single attempt, and the valve did not spontaneously change levels during the course of analysis. Therefore the conditions of this complaint could not be verified by laboratory personnel. It met the requirements for siphon, pressure-flow, pre-implantation, and leak testing. The valve did not meet the requirements for reflux testing. There was proteinaceous debris observed within the interior and exterior of the valve. Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid reflux. Instructions for use (ifu) that accompany the device caution that ¿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. ¿ 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 SNAP SHUNT, SMALL
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 Key7100323
MDR Text Key94258275
Report Number2021898-2017-00636
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number27816
Device Catalogue Number27816
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2017
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: 12/08/2017 Patient Sequence Number: 1
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