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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42866
Device Problems Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 11/21/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient was implanted in (b)(6) 2018. The patient had enlarged ventricles and the valve setting was set to 0. 5. Two days after implant, the patient was scanned and it was noticed that overdrainage occurred and the ventricles were constricted. The valve setting was adjusted to 1. 5, however the ventricles enlarged once more after the patient was scanned two days later. The valve was adjusted to 1. 0 and ventricles constricted again. A second doctor was called in to identify the cause of the underdrainage and overdrainage. The doctor noted that upon adjustment, the new adjusted pressure setting did not reflect the change, rather it still displayed the older setting. As the patient¿s condition was deteriorating, the doctor replaced the valve in (b)(6). The patient was doing well with the new valve. Following the explant, the old valve did not seem able to change settings when using both the handtools and stratavarius.
 
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Brand NameSTRATA II VALVE, REGULAR
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 Key8201280
MDR Text Key131583332
Report Number2021898-2018-00594
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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 Date02/28/2021
Device Model Number42866
Device Catalogue Number42866
Device Lot NumberE45681
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
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 Manufactured04/13/2018
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: 12/27/2018 Patient Sequence Number: 1
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