MAUDE Adverse Event Report: MEDTRONIC MEXICO RES 44200 VENTRICULOSTOMY BH 6MM REG IMP; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number 44200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 11/29/2022

Event Type  Injury  

Event Description

Medtronic received information regarding an external drainage and monitoring device for the indication of neuronal ceroid lipofuscinosis.The lot number for brineura was not reported.On (b)(6) 2022, the patient initiated treatment with brineura (300 milligram, frequency reported as "once").The time from the last dose to event onset was reported as three days.On (b)(6) 2022, liquor analysis was 104 x 10^6/l (reference ranges were not reported).Bacterial culture was positive for staphylococcus epidermidis.Prior to receiving the brineura infusion, a sample of cerebrospinal fluid (csf) was taken to check for cytosis, glucose, protein, and flora.The sample presented with cytosis 104 x 10, segmented neutrophils 59%, eosinophils 6%, monocytes macrophages 20%, and lymphocytes 15%.Ceftriaxone sodium was started.Despite the antibiotics therapy, the patient presented fever at night.Gram stain microscopy showed a gram-positive cocci (device related infection).Ceftriaxone sodium was then shifted to vancomycin hydrochloride.Despite the therapy, the repeated csf analysis showed inflammatory csf.Differential diagnosis included virus infection.A polymerase chain reaction (pcr) test was negative.The patient was transferred to the neurosurgery department and was scheduled for reservoir removal.The action taken with brineura due to the event was not reported.The reporter assessed the event of device related infection as related to the icv device.No other etiological factors were reported.The event, initially reported as device related infection has been updated by the reporter to ventriculitis/sample of cerebrospinal fluid was taken, gram positive cocci (cns ventriculitis).Concomitant medications included valproate sodium and levetiracetam.On an unspecified date, an icv device (medtronic (44200) was implanted.The reservoir device number was 44111.On (b)(6) 2022, the patient initiated treatment with brineura (300 milligram, frequency reported as "once").This time from the last dose to event onset was reported as three days.On (b)(6) 2022, liquor analysis was 104 x 10^6/l (reference ranges were not reported).Bacterial culture was positive for staphylococcus epidermidis.On (b)(6) 2022, the patient experienced fever of 37.3 degrees (unit not reported).Repeat analysis of liquor showed cytosis of 2.3 x 10^6/l.On the same date, the patient experienced ventriculitis/sample of cerebrospinal fluid was taken, gram positive cocci (cns ventriculitis) which required hospitalization.On (b)(6) 2022, fever was 38.5 degrees.On the same date, antibiotic was changed due to antibiotic resistance.Vinpocetine was started.From (b)(6) 2022 to (b)(6) 2022, fever persisted.On (b)(6) 2022, cytosis in liquor was 82.6 x 10^6/l and erythrocytes 96 x 10^6/l, segmented neutrophils 1%, monocytes-macrophages 37 %, and lymphocytes 62%.Biochemical analysis of liquor: protein: 0.18 g/l (reference range: 0.15-0.45); glucose 3 mmol/l (reference range: 2.3-3.9); and chlorides 128 mmol/l (reference range: 118-132).Bacterial culture was positive for staphylococcus epidermidis: staphylococcus, resistant to methicillin and ceftazidim.On (b)(6) 2022, the icv device was removed.The outcome of the event was reported as not recovered/not resolved.The reporter assessed the event as causing permanent disability.The icv device was not available for return.The reporter did not provide an assessment of the event of cns ventriculitis in relation to treatment with brineura.Per the reporter's opinion, other etiological factors were probable which included the patient's surgery.The investigator assessed the event of cns ventriculitis as related to treatment with icv device.

Manufacturer Narrative

No parts have been returned for analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: RES 44200 VENTRICULOSTOMY BH 6MM REG IMP
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 16621599
• MDR Text Key: 312131018
• Report Number: 9612164-2023-01293
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 44200
• Device Catalogue Number: 44200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 4 YR
• Patient Sex: Male