MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC LUMBOPERITONEAL SHUNT KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 44420

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

Patient Problem Unspecified Infection (1930)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Yan-hua su, chi-lu chiang, huai-che yang, yong-sin hu, yu-wei chen, yung-hung luo, ching-jen chen, hsiu-mei wu, chung-jung lin, and cheng-chia lee.Cerebrospinal fluid diversion and outcomes for lung cancer patients with leptomeningeal carcinomatosis.Acta neurochirurgica (2021).Doi: 10.1007/s00701-021-04763-w.Abstract objective to investigate the outcomes of cerebrospinal fluid (csf) diversion in lung cancer patients with leptomeningeal carcinomatosis (lmc).Methods a retrospective review of consecutive lung cancer patients with lmc suffering from increased intracranial pressure (iicp) and hydrocephalus between february 2017 and february 2020.We evaluated the survival benefit of csf diversion surgery and assessed the outcomes of treatments administered post-lmc in terms of overall survival and shunt-related complications.Results the study cohort included 50 patients (median age: 59 years).Ventricular peritoneal (vp) shunts were placed in 33 patients, and lumbar peritoneal (lp) shunts were placed in 7 patients.Programmable shunts were placed in 36 patients.Shunt adjustment was performed in 19 patients.Kaplan-meier analysis revealed that shunt placement increased overall survival from 1.95 months to 6.21 months (p = 0.0012) and increased karnofsky performance scores (kps) from 60 to 70.Univariate analysis revealed no difference between vp or lp shunts in terms of survival.No differences in post-shunt systemic treatments (tyrosine kinase inhibitors (tkis) or systemic treatments) were observed in overall survival.Shunt-related complications were noted in 7 patients, including shunt obstruction (n = 4), infection (n = 1), and over-drainage (n = 2).Conclusion csf diversion (vp or lp shunt) appears to be an effective and safe treatment for lung cancer patients with lmc and hydrocephalus.Programmable shunts should be considered for complex cases, which commonly require pressure adjustments as the disease progresses.Reported events.- infection was detected in 1 vp shunt patient (2.5%), which necessitated multiple revision surgeries.- shunt obstruction was detected in 3 vp shunt patients and 1 lp shunt patient (10% overall).Two cases of obstruction were treated using revision surgery and two underwent hospice care.

Event Description

Additional information received reported that one obstruction and one infection described in the article directly related to a medtronic device/product.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: 42836 strata burr hole valve, 42355 strata nsc burr hole valve 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: STRATA NSC LUMBOPERITONEAL SHUNT KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 11734177
• MDR Text Key: 247601649
• Report Number: 2021898-2021-00100
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K091312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44420
• Device Catalogue Number: 44420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention