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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA II VALVE, SMALL SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 42856
Device Problem Inaccurate Flow Rate (1249)
Patient Problems Headache (1880); Visual Impairment (2138); Vomiting (2144)
Event Date 10/09/2016
Event Type  Injury  
Manufacturer Narrative
The product was unavailable for return. Therefore an evaluation of the device performance was not possible. A review of the manufacturing records was not possible as no lot number was provided. All valves are 100% tested at the time of manufacture. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported to medtronic neurosurgery that the patient showed clear symptoms of underdrainage and device failure. According to the report, the patient experienced drowsiness, headaches, vomiting, and diplopia. A ct showed enlarged ventricles. Reportedly, the device was replaced with a new device, which worked better. It was stated the patient¿s diplopia and headaches had disappeared, but they still had amnesia.
 
Manufacturer Narrative
The returned valve was patent. The valve met the requirements for siphon, reflux, pre-implantation, and leak testing. However, the valve did not meet the requirements for pressure-flow 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 affecting the flow of fluid through the valve. The 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. ¿ a review of the manufacturing records was not possible as no lot number was provided. All valves are 100% tested at the time of manufacture. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATA II VALVE, 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
bob shokoohi
125 cremona drive
goleta, CA 93117
8055718725
MDR Report Key6113797
MDR Text Key60366690
Report Number2021898-2016-00423
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeNO
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 10/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number42856
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2016
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: 11/18/2016 Patient Sequence Number: 1
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