MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problems Positioning Problem (3009); Power Problem (3010)

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

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000221, serial/lot #: s2218dvq rev.J, ubd: , udi#: ; product id: bi71000463, serial/lot #: 50843278 rev.1, ubd: , udi#: ; product id: bi71000463, serial/lot #: 21648611 rev.1, ubd: , udi#: ; product id: bi71000221r, serial/lot #: s2218dvl, ubd: , udi#: (b)(4) h3: the system was serviced in the field, and the field representative replaced the digital drive board and calibrated the drive board.Codes b01, c07, d02 are applicable to this analysis.D9, h3: the hardware (bi71000463, 50843278 rev.1) was returned and analysis was performed.The reported complaint "driving issues" was unable to be confirmed.The strain gauge passed bench testing.The strain gauge was installed into a test system for several days.The system booted and readied.Forward, backwards, left and right driving was fully functional.No fault found while under test.B01, c19, d14 are applicable to this analysis.The hardware (bi71000463, 21648611 rev.1) was returned and analysis was performed.The reported complaint "driving issues" was able to be confirmed.The strain gauge failed bench testing, when testing continuity on pins 3 and 4, readings were very erratic / non-stable showing faulty strain gauge.B01, c07, d02 are applicable to this analysis.Hardware parts (bi71000221r and bi71000221) were returned but analysis had not yet been performed.Codes b21, c21, d16 are applicable.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

Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that this system was having issues driving.The board was dropping voltage when strain gauges are connected.No patient was present.Troubleshooting information was provided.The dmc board had been replaced the previous month.(b)(6)2023 (rep) e1: additional information was received.It was reported that the system would not drive at all.

Manufacturer Narrative

H2) device evaluation: d9 updated.H3, h6: the printed circuit board assembly (pcba) was returned to the manufacturer for analysis.Analysis found that the pcba was installed in the test imaging system.The system initialized.Motion, communication, generator and charging readied.40185vdc voltage measured across tp10 and tp23 and 4.191vdc across tp8 and tp23 confirm voltage drifted.Expecting voltages for both between 2.4vdc and 2.6vdc.Analysis found that the reported event was related to a electrical issue.B01, c02, d02 are applicable.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

H6: the motion control printed circuit board assembly (pcba) was returned to the manufacturer for analysis.Analysis found, that the motion control pcba was installed test imaging system.The system started beeping, during the boot up process.0.012vdc voltage measured across tp10 and tp23 and 3.476vdc across tp8 and tp23 confirm, voltage drifted.Unable to adjust tp10 potentiometer.Expecting voltages for both between 2.4vdc and 2.6vdc.Analysis found, that the reported event was related to a electrical issue.B01, c02, d02 are applicable.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: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16870203
• MDR Text Key: 314595400
• Report Number: 3004785967-2023-00277
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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