MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Nerve Damage (1979); Spinal Column Injury (2081); Iatrogenic Source (2498)

Event Date 06/24/2017

Event Type  Injury  

Manufacturer Narrative

Patient information was refused to be provided by the site.A medtronic representative reported that the camera positioning sensor unit (psu) was replaced for it had a weak laser light (and so possibly the aiming at the surgical field was not correct) and the field of view appeared rather short.The most likely cause of the connection issue between the navigation system and c-arm was that the site connected the systems with multiple interconnected videocables, not according to the operating instructions.This caused a weak or no video signal.The site also obstructed the c-arm target by not draping the target in the correct way.There was no malfunction found with the navigation equipment that could have caused the inaccuracy.The camera was replaced as discussed with the site.Video cable was replaced by site according to the operating procedure and instructions.Extra training on draping was performed with or staff.Multiple surgeries were supported without issue and with desired surgical outcomes.A medtronic representative went to the site to replace the positioning sensor unit (psu) and test the equipment.After replacement, the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The positioning sensor unit (psu) was returned to the manufacturer for analysis.The returned psu housing has yellowed considerably and both lenses were scratched.The blue label around the laser pointer had a bent corner.The laser pointer light was only functioning when the psu was powered.The laser pointer battery was dead.Otherwise, the psu passed an accuracy test at.06 mm with a passing threshold of.35 mm.The device was found to be fully functional.The reported event could not be duplicated by medtronic personnel.The laser handle was also returned and found to be fully function and unrelated to the reported event.

Event Description

Description of the incident: given the type of fracture l1 there was an indication to stabilize the th11-l3 range with the longitude system with navigation.Then an operation was planned, being a spondylodesis, two segments above the l1 fracture and two segments below.In the afternoon, the surgery was planned and the installation of the navigation system, however, it was found impossible to connect with the c-arm, essential for performing a navigated spondylodesis.After multiple startups, it was impossible to get a connection with the c-arm so that a navigated operation was not possible.At four o'clock at night the patient had a failure in the right leg.This was confirmed by the neurologist.To be sure of the correct position of the screws, a ct scan was organised and when studying the ct scan, it appeared that multiple placed screws were not optimal.Physician decided to perform revision surgery.The navigation system was removed and a new system was installed.Navigation was not possible with this operation.Re-positioning of the screws was completed.The new system was removed and patient was transferred to the intensive care.After the event, a medtronic representative followed up with the surgeon who reported that the patient was ok and doing fine.Lifting the patient's right foot is a bit difficult but this will get better overtime.There was no indication regarding the amount of inaccuracy apart from the reported 'not optimal'.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; attn:product quality experienc; louisville, CO 80027 ; 7208902082
• MDR Report Key: 7144099
• MDR Text Key: 95720858
• Report Number: 1723170-2017-04714
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/22/2017

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: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention