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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC STRATAMR VALVE AND SHUBT; SHUNT CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC MEDTRONIC STRATAMR VALVE AND SHUBT; SHUNT CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Device Problems Use of Incorrect Control/Treatment Settings (1126); Programming Issue (3014)
Patient Problems Headache (1880); Dizziness (2194)
Event Date 01/18/2018
Event Type  Injury  
Event Description
On (b)(6) 2018 (b)(6) began experiencing headache, dizziness, and the feeling his surroundings were spinning.He has a shunt to drain cerebrospinal fluid, the most recent implanted (b)(6) 2017.Since he uses a wheelchair he was unable to safely get out of bed.Dr.(b)(6) office was contacted thursday morning and again on friday.He was told he would need to wait until monday to determine when the tool needed to check his shunt would be available.Monday an appointment was scheduled.Dr.(b)(6) nurse and a medtronic technician check the shunt calibration and determined it was set on one when it should have been two.The shunt was reset to 2.No explanation was determined for why the setting changed.(b)(6) remained in bed flat on his back from thursday until the appointment on monday.
 
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Brand Name
MEDTRONIC STRATAMR VALVE AND SHUBT
Type of Device
SHUNT CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC
MDR Report Key7247353
MDR Text Key99332344
Report NumberMW5075095
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient Weight93
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