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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA BURR HOLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42836
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the valve did not drain. There were no patient symptoms or complications associated with the event. The valve was explanted and the patient¿s status was listed as alive ¿ no injury.
 
Manufacturer Narrative
The returned valve was patent. There was clear fluid inside the reservoir of the valve. It is unknown how or when this fluid entered the valve. The valve met the requirements of the magnetic flux test, reflux, siphon, leak, pressure flow and preimplantation. Therefore, the nature of the complaint could not be duplicated by the laboratory personnel. Proteinaceous debris was observed on the exterior of the valve and debris was on the interior of the valve. The ifu cautions that, ¿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 or may also hold pressure/flow controlling mechanisms open, resulting in overdrainage¿ 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.
 
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Brand NameSTRATA BURR HOLE VALVE
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 Key8200618
MDR Text Key131535725
Report Number2021898-2018-00590
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K083076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,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 Expiration Date11/30/2019
Device Model Number42836
Device Catalogue Number42836
Device Lot NumberE23052
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/27/2018 Patient Sequence Number: 1
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