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

Model Number BI70002000

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

Patient Problems High Blood Pressure/ Hypertension (1908); Unspecified Tissue Injury (4559)

Event Date 06/01/2022

Event Type  Death  

Manufacturer Narrative

Patient weight not available from the site.No parts have been received by the manufacturer for evaluation.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 in a sacroiliac and thoracolumbar procedure.It was reported that after exposing the patients spine, the first 3d spin was done on the lower region of the spine.During screw fixation of the lower region, there was a significant drop in the patient¿s blood pressure, which resulted in a temporary halt for the surgery.Anesthetist began infusing drugs to stabilize the patient.After the patient was stabilized, the surgeon began to continue the operation.A second 3d spin was executed.The surgeon and manufacturer representative (rep) verified the screws fixation of the lower region on the mobile view station (mvs).A breach was seen at the sacral region of the spine.The surgeon noted and continue with the procedure.A third 3d spin was executed for the upper region of the spine.The surgeon continued with the screws fixation of the remaining procedure.The anesthetist notified the surgeon to wrap up the procedure as soon as they could.Because the anesthetist mentioned t hat patient was very unstable and only seems to have been relying on drugs to be stabilized.A fourth 3d spin was executed, the surgeon then verified the upper region screws.The surgeon began to close the surgery after verifying the images.The patient went for a second surgery on (b)(6) 2022 to repair a torn vessel and died on the surgery table.No formal complaint was raised by the hospital against any inaccuracies from navigation.

Event Description

Additional information was received.It was unable to be determined in the torn vessel was due to the screw insertion.It was unknown which vessel was torn.There was no complaint from the surgeon regarding the position of the screw placement as it was verified with a 3d spin.After the first surgery the patient was sent to the intensive care unit (icu).The patient died during the second surgery.No other information was available and it was confirmed that very limited information was available due to patient confidentiality.There was no evidence that the patient's death was due to any inaccuracy.It was noted that non-medtronic instrumentation was being used with medtronic instruments.

Manufacturer Narrative

H2: additional information was received.B5 has been updated.Section d information references the main component of the system.Other relevant device(s) are: product id: unk_oarm_comp (software) h2/h3/h6: software analysis determined that this was a known software issue tracked in a medtronic database.Codes b01, c10 and 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: 15102674
• MDR Text Key: 296568622
• Report Number: 3004785967-2022-00484
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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
• Treatment: SEE H10
• Patient Outcome(s): Death
• Patient Age: 30 YR
• Patient Sex: Male