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

Model Number 44420

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

Patient Problems Emotional Changes (1831); Unspecified Infection (1930); Memory Loss/Impairment (1958); Dysphasia (2195); Ambulation Difficulties (2544)

Event Date 02/23/2022

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 accepted date of the literature article.Device lot number, or serial number, 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

Liu, j.T., su, p.H., the efficacy and limitation of lumboperitoneal shunt in normal pressure hydrocephalus.Clinical neurology and n eurosurgery.2020.193 (1-4) https://doi.Org/10.1016/j.Clineuro.2020.105748 objective to investigate whether the efficacy of the lumbar¿peritoneal (lp) shunt is sustainable, we measured the outcomes of patients with idiopathic nph (inph) preoperatively and postoperatively.Patients and methods we retrospective reviewed records of 58 patients with inph from 2013 to 2015.Exclusion of 7 patients expired, 1 patient shunt infection, and 8 patients was loss of follow-up.In the remaining 42 patients, the mood, talking response, movement, attention, recalling memory, and mini-mental state examination (mmse), representing patient outcomes, were measured.All of whom were follow-up for 3 years.Results mood (1.91 ± 0.30), talking response (1.98 ± 0.15), movement (1.71 ± 0.51), attention (1.95 ± 0.22), and recalling memory (1.86 ± 0.35) were significantly improved after surgery (1 week;p<(><<)>0.0001).However, the indicators significantly declined after 3 years (mood: 0.31 ± 0.52, talking response: 0.50 ± 0.59, movement: 0.17 ± 0.38, attention: 0.40 ± 0.59, recalling memory: 0.21 ± 0.42).The mmse was also significantly improved after 3 months of surgery (17.9 5 ± 2.80 vs.25.02 ± 3.36; p<(><<)>0.0001).However, it declined after 3 years (17.83 ± 3.66; p = 0.83).Conclusion the inph is considered potentially reversible.Our data supported that the lp shunt was efficient in the short term.However, the neurological degeneration was still progressive.Reportable events: one patient with a shunt infection mood, talking response, movement, attention, mms, and recalling memory declined after 3 years.

• Brand Name: STRATA®
• 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: 14937231
• MDR Text Key: 303922490
• Report Number: 2021898-2022-00147
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K091312
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 44420
• Device Catalogue Number: 44420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• 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: 79 YR
• Patient Sex: Female