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

Model Number S7

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Injury (2348); Iatrogenic Source (2498)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

The site declined to provide patient information, per (b)(6) privacy laws.Head frame is biocompatible - material intended for patient contact.On 03/08/2016 a medtronic representative, following-up at the site, was told the patient did require medical treatment for the bulla, however, details of treatment was unknown.No further details were provided.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative received a report from a site that that navigation with a navigation system was used for otorhinolaryngology surgery.After the procedure was completed, it was noted the patient had bulla on the forehead where head frame was attached.Tegaderm was put on the forehead of the patient and a seal was put on the tegaderm.The head frame was put on the seal and fixed with the use of headband.The site medical engineer is asking the medtronic representative if there is an action that can be taken as precaution to avoid bulla.There was no delay of therapy.The surgeon completed the procedure with the use of the navigation system.

Manufacturer Narrative

Correction: this event should have been reported as an adverse event only and not a product problem.A medtronic representative, following up with the site, reported that the tegaderm (non-medtronic product) was attached to the patient's forehead directly.This event was reviewed by a cross-function engineering team and found: the instructions for use, which accompanies the head frame device contains warnings and contraindications for use of the head frame and head frame adhesive.However, the head frame adhesive was not applied to the patient's forehead and therefore was not the cause of the adverse event.

• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5505115
• MDR Text Key: 40524086
• Report Number: 1723170-2016-00365
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2013
• 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