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

Model Number 9734686

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Migration (4003)

Patient Problems Headache (1880); Laceration(s) (1946); Dizziness (2194); Blood Loss (2597)

Event Date 05/14/2019

Event Type  Injury  

Event Description

Cervical spine surgery performed for correction of prior surgery.Headache and dizziness returned.Ct found that a screw had migrated and transected the vertebral artery resulting in bleeding.Patient also had suffered a stroke.Transferred to neuro icu.Third surgery performed to replace screw.Dizziness persists.Surgeon reports inaccuracy of equipment used on cervical cases-stealth navigation system resulted in screw placement being off.Fda safety report id # (b)(4).

• Brand Name: STEALTH
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION INC.
• MDR Report Key: 8722590
• MDR Text Key: 148998644
• Report Number: MW5087507
• Device Sequence Number: 2
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734686
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 63