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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-V
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Death (1802); Hemorrhage, Subdural (1894)
Event Type  Death  
Manufacturer Narrative
(b)(4). 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.
 
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Brand NameUNKNOWN 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 Key7382385
MDR Text Key103854523
Report Number2021898-2018-00171
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/29/2018
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 NumberUNKNOWN-V
Device Catalogue NumberUNKNOWN-V
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 Received03/01/2018
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

Patient Treatment Data
Date Received: 03/29/2018 Patient Sequence Number: 1
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