MAUDE Adverse Event Report: COVIDIEN LLC STRATA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-S

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

Patient Problem Unspecified Infection (1930)

Event Date 09/03/2021

Event Type  malfunction  

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

Nimni, m., weiss, p., cohen, c., laviv, y.Neuropsychological assessments and cognitive profile mostly associated with shunt surgery in idiopathic normal pressure hydrocephalus patients: diagnostic and predictive parameters and practical implications.Acta neurochirurgica 2021 (163) 3373¿3386.Https://doi.Org/10.1007/s00701-021-04976-z.Abstract background cognitive decline is a well-documented feature of idiopathic normal pressure hydrocephalus (inph) that can be reversible following cerebrospinal fluid tap tests (csf-tt).The current gold standard for selecting inph patients for shunt surgery is measurable improvement in gait tests following csf¿tt.However, the diagnostic significance and predictive role of pre-surgical cognitive evaluations in probable inph patients is still controversial.Purpose to find the neuropsychological (npsy) tests and cognitive aspects mostly associated with shunt surgery in inph.Material and methods a retrospective comparison between probable inph patients who, after undergoing csf¿tt with gait and cognitive evaluations, ended up receiving a shunt (group 1) and probable inph patients who ended up with no shunt surgery (group 2).Differences in the diagnostic and predictive results of variety of npsy tests at baseline, pre-csf-tt, and post-csf-tt were used for thorough statistical calculations.Results a total of 147 patients with probable inph were included.Of those, 58 (39.45%, group 1) patients underwent shunt surgery, while 89 (60.55%, group 2) did not.For the vast majority of the cognitive tests used, no statistically significant differences were found between the groups at baseline (pre-csf-tt).Following csf-tt, the ¿naming¿ component of the cognistat test was the only single test to show statically significant difference in improvement between the two groups.Combining at least two tests led to increased levels of accuracy and specificity; however, the sensitivity remained <(><<)>50.The only two combinations that were associated with sensitivity =70 were either any improvement in the congnistat test (p=0.627) or any improvement in either its naming, memory, or judgement components (p=0.015).Conclusion cognitive tests, even when combined to cover several cognitive aspects, are not sensitive enough to act as an independent reliable diagnostic and predictive tool, especially when relying on their scores as baseline.In order to avoid cumbersome and unnecessary tests to our patients and to reduce the number of patients who are denied proper treatment due to misdiagnosis, we recommend to use npsy tests that examine the cognitive aspects of naming and memory, in addition to 2¿3 tests for executive functions.Reported events 3 patients with a shunt infection.

• Brand Name: STRATA®
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15600722
• MDR Text Key: 306997201
• Report Number: 9612501-2022-01772
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• 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 Age: 74 YR
• Patient Sex: Male