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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
Catalog Number 42866
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Headache (1880); Neurological Deficit/Dysfunction (1982); Visual Impairment (2138)
Event Date 05/24/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported the cause of the shunt malfunction was not determined. The physician believed there was a valve failure possibly variable in "presentation. ".
 
Manufacturer Narrative
The product was unavailable for return. Therefore an evaluation of the device performance was not possible. A review of the manufacturing records was not possible as no lot number was provided. All valves are 100% tested at the time of manufacture. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported to medtronic neurosurgery that a patient with a history of acute obstructive hydrocephalus with a ventriculoperitoneal (vp) shunt that was placed 7 years ago presented approximately 3 months ago with reports of increased headaches, visual disturbances including diplopia, and ataxia; a shunt malfunction was diagnosed. It was confirmed that during an examination 3 years ago, the device showed normal function and worked well until a few months ago. The patient was taken to the operating room and the shunt was revised; a new distal system and valve were implanted. It was confirmed that the ventricular catheter worked well, but the patient presented again on several occasions with reports of "what [the patient] thought were low pressure headaches"; a shunt problem was reported. According to the report, there was a small curve of the distal catheter that was caudal to the anti-siphon device. The health care provider (hcp) thought this could be the cause of the previously noted problem, so a revision was performed. It was then reported that this was not the cause of the problem as the problem appeared to be in the valve system. The ventricular catheter was cut proximal to the shunt and a brisk ingress of spinal fluid, which was perfectly clear and under relatively high pressure, came out of the ventricular catheter without any event; a rubber shod was placed immediately. According to the report, it was concluded that there was a failure somewhere within the system of the valve and anti-siphon device. The patient's medical history included the following: copd, vp shunt placement approximately 7 years ago, headaches, and ataxia.
 
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 Key6778991
MDR Text Key103783778
Report Number2021898-2017-00433
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number42866
Device Lot NumberE10144
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/29/2016
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: 08/09/2017 Patient Sequence Number: 1
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