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

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Tissue Damage (2104); Brain Injury (2219); Therapeutic Response, Decreased (2271); Iatrogenic Source (2498); No Information (3190)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

During the onsite inspection, the medtronic representative reported that the system operated within specifications.The reported issue was not confirmed.

Event Description

A medtronic representative reported that the had been experiencing inaccuracies with the cranial application (specifically optical navigation).

Manufacturer Narrative

Additional information: a medtronic representative reported the reported issue has not reoccurred with the navigation system.It was reported that the site uses forceps to remove the spheres from the instruments which is not the recommended practice.Following the report of the forceps being used.The probable cause of the anomaly would be linked to a use error.The software investigation found that the reported event was unrelated to a software issue.The software functioned as designed.

Manufacturer Narrative

Correction: a medtronic representative reported that some of these inaccuracies have resulted in patients coming back for re-do craniotomy.They were not able to provide how inaccurate the system was.The case was not delayed.They found at a later date that the tumor was not biopsied.They got results for normal brain tissue back from pathology.No patient demographics were provided despite multiple attempts from the surgeon and site staff.The following 3 related mdrs were submitted based on the above allegations of multiple patient events: 1723170-2017-01004, 1723170-2017-01001, 1723170-2017-01002.Additional information: a medtronic representative reported that he tested instruments and one probe was found to have slightly higher geometry error and was replaced (this probe was returned for evaluation and found to be fully functional and unrelated to the cause of the reported event).The rep found that after replacing chipped and scratched spheres, he was able to improve the instruments accuracy.He also found that "the locking mechanism on the mayfield (non-medtronic device) had play in it allowing the head to move" when he bumped in to the demo head after he had accuracy confirmed with frame, probe and demo head.Demo head moved about 1/4" caused about 2-3 mm inaccuracy.The reps checked all mayfields at site, found every one of them had slight play when it was locked.One of them had about double the movement than the others.It was recommended that the mayfields rep check out their devices.The rep also completed in-service training with the navigation coordinator at the site.The instructions for use (ifu) that accompanies the device contains warnings regarding the use of damaged spheres.

• 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: 6377053
• MDR Text Key: 69039168
• Report Number: 1723170-2017-01003
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• 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): Required Intervention