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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC STRATA MR SHUNT VALVE

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MEDTRONIC STRATA MR SHUNT VALVE Back to Search Results
Device Problems Incorrect Software Programming Calculations (1495); Programming Issue (3014)
Patient Problems Neurological Deficit/Dysfunction (1982); Hernia (2240); Hydrocephalus (3272)
Event Date 01/29/2017
Event Type  Injury  
Event Description
Patient has a history of neurofibromatosis and was found to have aqueduct stenosis/obstruction from lesions. Anatomy was not amenable to endoscopic third ventriculostomy, so she underwent placement of a right ventriculoperitoneal shunt with a strata mr valve on (b)(6) 2016. She presented in acute malfunction with severe symptoms concerning for impending herniation on (b)(6) 2017 and had her shunt externalized. Her shunt was re-internalized on (b)(6) 2017 using the same strata mr valve as it did not appear to be faulty intraoperatively. Patient, however, re-presented with similar acute and severe presentation on (b)(6) 2017 requiring a repeat externalization. Strata mr valve was removed. When the shunt was re-internalized, a strata ii valve was used instead. The previous strata mr valve was unable to be successfully programmed and was getting stuck in between settings, resulting in limited to no drainage through the shunt system. Patient presented in extremus with severe and life-threatening neurological changes due to the repeated valve malfunction. Valve was tested with manometer after explantation and was found to have inadequate drainage for a setting of 0. 5 or 1. 0. Dates of use: (b)(6) 2016 - (b)(6) 2017. Diagnosis or reason for use: hydrocephalus. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: yes.
 
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Brand NameSTRATA MR SHUNT VALVE
Type of DeviceSTRATA MR SHUNT VALVE
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6352547
MDR Text Key68248964
Report NumberMW5068029
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/20/2017 Patient Sequence Number: 1
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