MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9734056

Device Problems Imprecision (1307); Data Problem (3196)

Patient Problems Paralysis (1997); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2022

Event Type  Injury  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.Concomitant medical products: other relevant device(s) are: product id: 9735585, version #: 3.1.2.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used intraoperatively during a tumorectomy.It was reported that registration was completed, accuracy was checked and the operation proceeded based on the judgement that there were no problems.During the operation, a craniotomy was performed using navigation and an attempt was made to perform a tumorectomy, but the tumor could not be found.The center of the tumor was pointed out in the navigation image, but it was not the tumor tissue.No tumor was observed when it was checked by echo.After checking the postoperative computed tomography (ct) images, it was determined that they had touched the brain about 5 cm behind the position of the tumor on the magnetic resonance imaging (mri) image.There was a difference from the points shown in the intraoperative navigation.The surgery was ended and postponed without completing the objective of the procedure.Additional information was received following the procedure.Accuracy was checked using the head 3 head part model, but there were no inaccuracies in all areas.The assistant physician in the surgery also confirmed that there were no problems with accuracy.The opinion was heard that the merge was not functioning properly.Upon checking the stealthmerge in the cranial application, it was confirmed that the image was verified without matching the anatomical shape.It was registered in ct images, and mr images were merged into ct images.It was known that the cause was navigation using mr images where the merge of mr image remained incomplete.

Event Description

Additional information was received.It was reported the paralysis int he right hand and the right leg was a result of the procedure.It was unknown if there was any surgical delay.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Manufacturer Narrative

H3: a software analysis was initiated to determine the probable cause of the issue.Software analysis did not capture any noticeable errors related to the reported issue and was not caused by the system malfunctioning.There were no failures found.H6: codes b01, c19 and d14 apply to this software analysis.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: CART 9734056 S7 STAFF SHRT 100-120V INTL
• 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: 14565064
• MDR Text Key: 293077746
• Report Number: 1723170-2022-00839
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 9734056
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2019
• 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
• Treatment: "SEE H10."
• Patient Outcome(s): Required Intervention