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

Model Number UNKNOWN-C

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Scar Tissue (2060)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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

Yamashita, s., kimiwada, t., hayashi, t., shirane, r., tomonaga, t.Reconversion to ventriculoperitoneal shunt following ventriculoatrial shunt malfunction in children.Child's nervous system.2021.(37) 2207-2213.Https://doi.Org/10.1007/s00381-021-05045-7 purpose to analyze the long-term efficacy of the ventriculoatrial shunt (vas) in pediatric patients with hydrocephalus, focusing on the atrial catheter and suitable revision procedures of the distal catheter following vas malformation performed at our institution.Methods the authors retrospectively analyzed data of 28 pediatric patients under the age of 10 years who were treated with vas for h ydrocephalus and who had a follow-up period of at least 5 years.Results a total of 42 atrial tube revision procedures were performed in 28 patients during the study period.The median atrial tube survival time due to atrial tube obstruction was 2.32 years (n = 31, range: 0.4¿8.08 years).Atrial tube survival time was shorter in younger children (p <(><<)> 0.0001) and in children who were shorter in height (p = 0.0001).As a revision procedure following atrial tube malfunction, 22 (78.6%) out of the 28 patients who had an inserted vas had the vas reconversion into a vps at the last follow-up.Conclusions vas can be a useful alternative to vps, but it requires frequent atrial tube revisions, especially in younger children.Reconversion to vps after vas malfunction is a reasonable option and is associated with longer shunt survival time despite its previously observed difficulties.Reported events: 31 patient hadrevisions due to tube obstructions 6 patients had revisions due to infections 5 patients had elective revision atrial tube lengthening to prevent catheter obstruction 23 cases of reconversion to vps including removal of the atrial tube and insertion of the peritoneal tube 12 cases of atrial tube replacement 6 cases total vas removal because of csf infection 2 cases of abdominal pseudocysts 1 case of vps infection, and they underwent reconversion to vas again 1 case of abdominal adhesions 1 case of ascites 2 cases of small peritoneal cavity 1 case of necrotizing enterocolitis 1 case of stoma see attached literature article.

Manufacturer Narrative

H2) please see regulatory rep #: 2021898-2021-00226 for addition information.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 CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14174449
• MDR Text Key: 294124731
• Report Number: 2021898-2022-00102
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• 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): Other
• Patient Age: 9 MO
• Patient Sex: Male