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 Bacterial Infection (1735); Fever (1858); Unspecified Tissue Injury (4559)

Event Date 11/29/2022

Event Type  Injury  

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.

Event Description

Medtronic received information regarding a reservoir.On an unspecified date, the patient initiated treatment with a competitor (the dose frequency were not reported; intracerebroventricular use) for indication of neuronal ceroid lipofuscinosis.On (b)(6) 2022 prior to receiving the competitors infusion, the patient had a sample of their cerebrospinal fluid (csf) taken to check for cytosis, glucose, protein, and flora.The sample presented with cytosis, segmented neutrophils, eosinophils, monocytes, macrophages, and lymphocytes.Medication was started.Despite the antibiotics therapy, the patient presented a fever.The gram stain microscopy showed gram-positive cocci (a device related infection).A different type of medication was then started.Despite the therapy, the repeated csf analysis showed inflammatory csf.Differential diagnosis included virus infection.A polymerase chain reaction test was negative.The patient was transferred to the neurosurgery department and was scheduled for removal of the medtronic reservoir.The action taken with the competitor was due to the event was not reported.The reporter did not provide an assessment of the event of the device related infection in relation to treatment with the competitor.The reporter assessed the event of device replaced infection as related to the "icv" device.No other etiological factors were reported.2022-dec-11 additional information was received from the health care professional stating that cerebrospinal fluid (csf) fluid was taken from the patient and it was gram positive cocci.On (b)(6) 2022 the patient initiated treatment with the competitor.The time from the last dose to event onset was reported as three days.The bacterial culture was positive for staphylococcus epidermidis.(b)(6) 2022 the patient experienced a fever of 37.3 degrees (unit not reported).On the same date, the patient experienced ventriculitis/sample of csf was take, gram positive cocci which required hepatization.Medication was started.From (b)(6), 2022, fever persisted.On (b)(6) 2022 bacterial culture was positive for staphylococcus epidermis: staphylococcus, resistant to methicillin and ceftazidim.On (b)(6) 2022, the medtronic device was removed.The reporter assess the event as causing permanent disability.The reporter did not provide an assessment of the event of cns ventriculitis in relation with our competitor.Per the reporter's opinion, other etiological factors were probable which included the patient' surgery.The investigator assessed the event of cns ventriculitis as related to treatment with the competitor.Additional comments on the case stated that the patient experienced a device related infection, which is a known complication of the icv device use.The causality of the event is assessed as not related to the competitor.The event initially was reported as a device related infection and was updated to cns ventriculitis which is a known complication of icv device use.The causality of the event is assessed as not related to the competitor.

• 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: 16095050
• MDR Text Key: 306615824
• Report Number: 9612164-2023-00054
• 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: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 12/14/2022
• 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; Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male