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

Model Number 9734056

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the camera was not recognized.An operation check determined that there was no problem with the camera, but the polaris spectra system control unit (scu) was defective.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: scu 9733438 p olaris camera.No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: scu 9733438 p olaris camera.No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the camera was not recognized.An operation check determined that there was no problem with the camera, but the polaris spectra system control unit (scu) was defective.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the positioning sensor unit (psu) and polaris spectra system control unit (scu) for the navigation system were replaced.The navigation system then passed the system checkout and was found to be fully functional.Continuation of d10) pn: 9733438, 9735346r.Ln/sn: unk, unk 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

Information references the main component of the system.Other relevant device(s) are: product id: 9733437r, sn/lot# unknown.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: the positioning sensor unit (psu) was returned to the manufacturer for analysis.Analysis found that the psu would not power up on the bench test.Analysis found that the reported event was related to a electrical issue.The polaris spectra system control unit (scu) was returned to the manufacturer for analysis.The scu was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.H6: fdm b01, fdr c02, and fdc d02 are applicable to the psu hardware analysis.Fdm b01, fdr c19, and fdc d14 are applicable to the scu hardware 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.

Manufacturer Narrative

H3: a medtronic representative went to the site to test the equipment.Testing revealed that parts were replaced.The navigation system then passed the system checkout and was found to be fully functional.H6: fdm b01, fdr c13, fdc d02 are applicable to the system checkout.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: 12985134
• MDR Text Key: 285480962
• Report Number: 1723170-2021-02874
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9734056
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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