MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number UNK_NAV_SYS

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 02/03/2022

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patients in the study.Patient weight not available from the site.Event date is the accepted date of the publication.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is dependent on the device lot/serial number, therefore is 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

Citation: charlotte sommer meyer, kresten rickers, & søren peter eiskjær.Magnetically controlled growing rods in early-onset scoliosis.Danish medical journal.2022;69(4): a08210627.Abstract: introduction.Early-onset scoliosis (eos) may result in disability and a reduced life expectancy.The aim of this study was to report the results of primary magnetically controlled growing rods (mcgr) in a consecutive group of patients with eos diagnosed and operated at (b)(6) university hospital, (b)(6), from 2009 and onwards and with at least two years of follow-up.Methods.Data were extracted from the electronic patient records and the picture archiving and communication system.All data were extracted by an unbiased observer.Demographics, any complication and the cobb angles and maximal kyphosis angles preoperatively and post-operatively were recorded.Likewise, the total expansion of the mcgr and the increase in t1-t12 and t1-s1 heights were recorded.Results.A total of 15 patients (three females) were followed for an average of 3.75 years.The cobb angles were corrected on average by 68% and the maximal kyphosis angle by 45%.The thoracic height increased significantly with only two patients (still undergoing expansions) with a t1-s1 height below 22 cm.Four complications were recorded (one deep infection and three non-functioning rods), all resulting in rod exchange.The complication rate was (b)(4) per patient per year.Conclusions.The mcgr may reduce the deformity and support thoracic and pulmonary growth without any need for repeated surgeries.The number of complications in the present series was low compared with the literature with an average of 0.07 complications per year per patient or a total complication rate of (b)(4).Reported events: one rod required revision due to a deep wound infection.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14474024
• MDR Text Key: 294776591
• Report Number: 1723170-2022-00787
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Sex: Male