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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-S
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fatigue (1849); Headache (1880); Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Date 12/27/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient went to a follow-up appointment on (b)(6) 2018 with complaints of a pressure-like sensation in their head. The patient complained of incisional pain from their shunt replacement surgery, however, noted that the pressure was a different sensation from their incisional pain. A ct scan of their head was obtained which did not show much change in their ventricle size when compared to previous imaging. The doctor adjusted the patient's setting from 1. 5 to 0. 5. They checked their shunt 2 times after the adjustment and got 0. 5 both of those times. On (b)(6) 2019, the patient again went in for a follow-up appointment due to dealing with daily headaches. It was stated the headaches at times could become quite severe. They were taking a generic form of excedrin on a daily basis. The patient also noted they had felt more sleepy since the shunt was put in. A ct scan of their head was performed and showed a decrease in the size of their ventricles. There was no evidence of subdural, subarachnoid, or intraventricular blood. The shunt was then adjusted to 1. 0 to see if that improved their headaches.
 
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Brand NameUNKNOWN STRATA VALVE/SHUNT
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 Key8927145
MDR Text Key156948070
Report Number2021898-2019-00320
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 Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 08/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-S
Device Catalogue NumberUNKNOWN-S
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 Received08/14/2019
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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