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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAVARIOUS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STRATAVARIOUS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 45806
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Hemorrhage, Subdural (1894); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
Using a new set of batteries and a strata program card, the unit was found to power on and upon inspection of the battery compartment and magnet were in good condition. It was found that the stratavarius able to read the pl setting but was not able to be adjust the valve. A known good set of hand-tools were able to adjust and read the pl of the valve. Please also see report number 2021898-2018-00171. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the clinic was having issues with their stratavarious programmer. It was then reported that the valve could not be adjusted. Follow up indicated that the patient's settings were changed from 1. 5 to 1. A few days after this change, the patient experienced a "large acute subdural" so the shunt was adjusted from 1. 0 to 2. 5 so their ventricles would enlarge and "push the collection post-op". During the second follow-up, it was noticed that the ventricles were not enlarging and the patient developed a large hygroma on the opposite side; the settings did not actually change. The shunt was checked again and it was noticed that the settings reverted to 1. 0. The settings were again dialed to 2. 5 and confirmed by the health care provider (hcp). The following day, it was again discovered the settings were at 1. A manual magnetic adjustment tool was used and the device was set to 2. 5; the ventricles enlarged. It was then reported that the patient has "since passed on". The hcp questioned if the root cause of the hematoma was due to inaccurate s tratavarius adjustment. Please see report number 2021898-2018-00171.
 
Manufacturer Narrative
Further analysis confirmed that the device correctly read the pl settings of the test valve. However, the magnet adjustment tool in the kit with the device would not correctly adjust the valve. During the examination, the plastic case of the adjustment tool popped open and the internal magnet assembly fell out. The plastic tabs holding the case together were observed to be damaged, and the internal epoxy filler holding the magnet assembly in place inside the case had broken loose. Once the magnet assembly was put back inside the adjustment tool case in the correct factory orientation, and the case was closed back up, the adjustment tool correctly adjusted the test valve. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATAVARIOUS
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 Key7382397
MDR Text Key103857753
Report Number2021898-2018-00172
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45806
Device Catalogue Number45806
Device Lot Number12133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2018
Was Device Evaluated by Manufacturer? Yes
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: 03/29/2018 Patient Sequence Number: 1
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