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

Model Number UNK_NAV_SYS

Device Problem Imprecision (1307)

Patient Problems Stroke/CVA (1770); Headache (1880); Hemorrhage/Bleeding (1888); Dizziness (2194)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.Device model number, serial number, and udi unavailable.E: initial reporter and facility unknown.System was not evaluated because system and facility are unknown.If information is provided in the future, a supplemental report will be issued.[mw5087507].

Event Description

Medtronic received information regarding a navigation system being used for a cervical spine procedure.It was reported via medwatch form to the fda that screw placement was inaccurate after using a navigation system.The medwatch form stated a cervical spine surgery was performed for correction of a prior surgery.It was noted headache and dizziness returned.A computed tomography (ct) found a screw had migrated and transected the vertebral artery resulting in bleeding.The patient also had suffered a stroke and was transferred to neuro intensive care unit (icu).A third surgery was performed to replace screw.It was noted dizziness persisted.No further information was available.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: ORTHOPEDIC 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9125434
• MDR Text Key: 161194208
• Report Number: 1723170-2019-05024
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/26/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 09/26/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention