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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-VENTRICULOSTOMY RESERVOIR, BURR HOLE, 6MM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY CSF-VENTRICULOSTOMY RESERVOIR, BURR HOLE, 6MM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 44200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Fever (1858); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Swelling (2091); Vomiting (2144)
Event Date 11/14/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent implantation of the intracerebral ventriculostomy (icv) set on (b)(6) 2016. On (b)(6) 2016,<(>,<)> the patient initiated treatment with bmn 250 (100 milligram, qw, icv). On (b)(6) 2018, the patient's bmn 250 was administered, and on (b)(6) 2018, the patient had a fever (maximum of 38. 7ºc) and was vomiting. The emergency department observed rigidity of the patient's neck and swelling of the icv. Also the patient seemed to have pain when touching the icv and alternate episodes of drowsiness. Grade 3 meningitis was suspected and a blood test was performed with normal result (short evolution time). A cerebrospinal fluid (csf) sample was obtained from the reservoir, which was turbid. The hospital admission was decided and intravenous antibiotic therapy with cefotazime and vancomycin was started. On (b)(6) 2018, in the morning the patient only presented with low-grade fever. Given that the analysis of csf including gram was negative, it was decided to perform a lumbar puncture that showed cell elevation (around 1000/ml) at the expense of polymorphonuclear cells and hypoglycorrhachia. It was decided to remove the icv device by surgery and the patient continued with intravenous antibiotics for approximately 15 days pending the result of the cultures. A brain nuclear magnetic resonance imaging was also performed and it did not show significant alterations or intracranial complications such as abscess or obstruction to the circulation of cerebrospinal fluid. Treatment with bmn 250 and the icv device was withdrawn due to the event. The outcome of the event was reported as recovered/resolved on (b)(6) 2018. The investigator updated the primary event from meningitis to device related infection. The investigator assessed the event of device related infection as not related to treatment with bmn 250. The investigator assessed the event of device related infection as related to the subject's icv device.
 
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Brand NameCSF-VENTRICULOSTOMY RESERVOIR, BURR HOLE, 6MM
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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key9173079
MDR Text Key161838859
Report Number2021898-2019-00361
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K874498
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number44200
Device Catalogue Number44200
Device Lot NumberUNKNOWN
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 Received09/30/2019
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

Patient Treatment Data
Date Received: 10/09/2019 Patient Sequence Number: 1
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