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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 Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fatigue (1849); Nausea (1970); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient had been having problems with their valve that was implanted last year, and had been needing several adjustments. It was stated they weren't draining enough. The patient was meeting with their surgeon next week. The patient's history included a posterior arachnoid cyst and hindbrain chiari malformation.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported the patient has had the shunt about 2 months and then started getting an increase in head pressure, sleepy, nauseated, and difficulty moving. They had reported to the neurosurgeon who had adjusted the shunt. This was the second time the shunt had been adjusted since the surgery. It did not relieve the symptoms. The patient has a follow-up appointment 3 months from now.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key8486435
MDR Text Key141025018
Report Number2021898-2019-00138
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number42866
Device Catalogue Number42866
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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