MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-C

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

Patient Problems Abscess (1690); Fever (1858); Convulsion/Seizure (4406); Swelling/ Edema (4577)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient's study treatment was initiated on (b)(6) 2020, and their most recent dose of ax 250 received prior to the right frontal intra-axial brain injury (intracranial abscess) was on (b)(6) 2020.The patient's relevant medical and surgical history included pneumonia, gastroenteritis, allergic rhinitis, umbilical hernia, hepatomegaly, hydromes, epilepsy and cerebrospinal fluid protein elevation.Relevant concomitant medications taken within 14 days of the intracranial abscess onset included oxcarbazepine.On (b)(6) 2020, the patient presented with an episode of disconnection with the environment and later with tonic-clonic movements of msi that yielded.The patient was transferred to the emergency room for care and upon admission, they presented with a new episode requiring resuscitation, considering the episode of local seizure status.Management for convulsive status was started, paraclinics and neuroimaging were performed.The subject presented with 4 focal seizure episodes in total.Upon admission, the patient was also noted to be feverish.A computed tomography (ct) of the skull revealed an intra-axial lesion of oval morphology with dimensions of 22 x 22 x 26mm in the right frontal lobe.It presented a hypodense center with a slightly hyperdense peripheral halo.The lesion produced a vasogenic edema and a mass effect.The site reported that the lesion was an abscess due to contiguity and contamination of the catheter.The patient was hospitalized for study and management and was started on a two-week course of antibiotics.On (b)(6) 2020, a brain magnetic resonance imaging (mri) with contrast was performed, which confirmed the diagnostic suspicion.After resuscitation management for seizures, the patient had not presented any new seizures or fever peaks and had been thermodynamically stable.On (b)(6) 2020, the patient underwent surgery to remove the catheter and abscess.The catheter was confirmed to have been in the ventricle and the patient was receiving their doses of ax 250 in the ventricle.Intraventricular fluid was clear.The catheter was not inside the abscess; the abscess adhered to the catheter on its medial wall.The catheter, capsule, and content were sent for culture.The patient was transferred to the intensive care unit in stable, well condition.The event was ongoing at the time of report (recovering).The investigator assessed the right frontal intra-axial brain as nci ctcae grade 3 in severity, and related to the device, not the study drug.

Event Description

Additional information received reported that the site clarified the abbreviation "msi" as left upper limb.The patient's treatment included midazolam and phenytoin for the convulsive state, ketamine and midazolam for sedation, anti-inflammatory treatment with dexamethasone, and antibiotic treatment with ceftriaxone, vancomycin, metronidazole, and meropenem.The patient completed their course of antibiotics, and it was reported that all cultures were definitely negative.A post-operative ct scan was completed which showed resolution of the collection.The site confirmed the focal seizures were controlled, had easily resolved, and the duration of the seizures were unknown.In approximately the first week of (b)(6) 2020, the patient was discharged from the hospital and was reportedly doing very well.On (b)(6) 2020, the patient was expected to undergo magnetic resonance imaging of the brain.The site confirmed it planned to discuss the patient's continuation in the study and afterwards, catheter replacement to restart infusions.

Manufacturer Narrative

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

Additional information received reported that event term was updated to abscess without germ found as it was previously reported as right frontal intra-axial brain injury.The investigator assessed the abscess without germ found as nci ctcae grade 4 in severity and not related to study drug.The investigator assessed the event as related to the device.

Manufacturer Narrative

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

Additional information received reported that the investigator assessed the right frontal intra-axial brain injury as nci ctcae grade 4 in severity and not related to study drug.The investigator assessed the event as related to the device.

Manufacturer Narrative

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.

Event Description

Additional information received reported that the patient was discharged on (b)(6) 2020.The site confirmed that the patient's catheter insertion was not yet scheduled due to the covid-pandemic.

Manufacturer Narrative

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.

Manufacturer Narrative

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

Additional information received reported that further clarification for the verbiage "resuscitation" per the site: the patient did not require resuscitation or present with cardiopulmonary arrest.Post-seizure, in the emergency room, vital signs were blood pressure 108/56 mmhg, mean arterial pressure (map) 73 mmhg, heart rate 141 beats/minute, respiratory rate 25 respirations/minute, fio2 100%, o2 saturation 100%, and temperature 38 degrees celsius.Then, the patient experienced a new seizure.Status epilepticus was considered and management was performed with benzodiazepines (midazolam), and the seizures subsided.On november 18.2020, an mri of the brain showed a right frontal intra-axial lesion, corresponding to the abscess in relation to the peritoneal ventricular bypass catheter path.On december 2, 2020, the post-operative ct scan showed resolution of the collection.Relevant concomitant medications taken within 14 days of sae/eosi onset also included loratadine and ondansetron.The site confirmed that the study drug infusion would be re-started on march 3, 2021.

• Brand Name: UNKNOWN CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 10880394
• MDR Text Key: 217928763
• Report Number: 2021898-2020-00345
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 20