MAUDE Adverse Event Report: MEDTRONIC MEXICO UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number UNKNOWN-E

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

Patient Problem Unspecified Infection (1930)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

H3) 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

Mian sy et al.Comparison of external ventricular drains with ventricular access devices for the emergency management of adult hydro cephalus.World neurosurg.2023 jun 26:s1878-8750(23)00862-8.Doi: 10.1016/j.Wneu.2023.06.091.Abstract objective: we compared external ventricular drains (evds) with percutaneous continuous cerebrospinal fluid (csf) drainage via ventri cular access devices (vads) for the acute management of hydrocephalus in adults.Methods: this was a retrospective review of all ventricular drains inserted for a new diagnosis of hydrocephalus into noninfected csf over four years.We compared infection rates, return to theatre, and patient outcome between evds and vads.We explored the effect of duration of drainage, frequency of sampling, hydrocephalus aetiology, and catheter location on these outcomes using multivariable logistic regression modelling.Results: we included 179 drains (76 evds and 103 vads).Evds were associated with a higher rate of unplanned return to theatre for r eplacement or revision (27/76, 36%,vs.4/103, 4%, or: 13.4 95%ci: 4.3-55.8).However, infection rates were higher in vads (13/103, 13% vs.5/76, 7%, or: 2.0, 95%ci: 0.65-7.7).Evds were 91% antibiotic impregnated whereas vads were 98% nonimpregnated.In multivariable analysis, infection was associated with duration of drainage (median: 11 days prior to infection for infected drains vs.7 days total for noninfected drains), but not drain type (vads vs.Evds or: 1.6, 95%ci: 0.5-6).Conclusions: evds had a higher rate of unplanned revisions but a lower infection rate compared to vads.However, in multivariable analysis choice of drain type was not associated with infection.We suggest a prospective comparison of antibiotic impregnated vads and evds using similar sampling protocols to assess whether vads or evds for acute hydrocephalus have a lower overall complication rate.Events: serious injuries associated with external ventricular drains: there were 27 unplanned return to theatre for drain replacement or removal.There were 5 infections at anytime and 3 infections within 30 days.The infections were managed with the following methods; 8 were intrathecal antibiotics, 5 were drain removal, 3 were with new drain insertion for infection.There was 1 outcomes of shunt insertion.

Manufacturer Narrative

H10) attachment added.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: UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM
• 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: 17483138
• MDR Text Key: 320663401
• Report Number: 9612164-2023-03584
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN-E
• Device Catalogue Number: UNKNOWN-E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male