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

Model Number S7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Brain Injury (2219); Iatrogenic Source (2498)

Event Date 10/31/2014

Event Type  Injury  

Manufacturer Narrative

Patient ids and weights were requested from the author, but not received.Citation: lee dj, zwienenberg-lee, m, seyal m, shahlaie k.Intraoperative computed tomography for intracranial electrode implantation surgery in medically refractory epilepsy.J neurosurg.2015; 122: 526¿531.Doi: 10.3171/2014.9.Jns13919.Depth electrodes are often placed with a high degree of accuracy using stereotactic guidance but can occasionally be malpositioned as a result of errors in depth placement and/or lead deviation.Subdural grid and strip electrodes are more prone to suboptimal positioning since they are sometimes passed through a bur hole or beyond craniotomy edges.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.No malfunction is alleged, therefore no device evaluation is required.

Event Description

In their article entitled, intraoperative computed tomography for intracranial electrode implantation surgery in medically refractory epilepsy, lee, zwienenberg-lee, seyal, & shahlaiein write that in this retrospective study, they evaluated 10 consecutive patients who had undergone subdural and/or depth electrode implantation for epilepsy monitoring between november 2010 and september 2012.The patient series included 6 women and 4 men, with an average age of (b)(6) years.All patients underwent placement of subdural electrodes (strips and/or grids), and 8 of the 10 patients had mesial temporal lobe depth electrodes placed as well (table 1).The stealthstation cranial software package (medtronic inc.) is used, with the brain biopsy module selected for electrode planning.Surgical plans are developed for subdural electrode placement.Placed in 10 patients using ict confirmation; the series included 45 temporal lobe strips, 48 frontal lobe strips, and 11 grid arrays.Four strips were replaced because of suboptimal positioning, including 1 anterior temporal and 3 inferior/ventral temporal strips.Thirty depth electrodes were placed in 8 of the 10 patients using ict to confirm final implantation.Postoperative ct scans were also obtained in the first 3 patients in this series and were identical to the ict scans with respect to electrode lead locations.One depth electrode was replaced because of suboptimal positioning of the electrode tip, which was posterior and lateral to the intended hippocampal target.There were no surgical site infections in this clinical series.In cases in which electrode repositioning was performed, the operative time was prolonged approximately 12 minutes to reposition electrodes and confirm final location with a repeat ict scan.

Manufacturer Narrative

This event was reviewed by a cross-functional engineering team who determined: the use of the "brain biopsy module" for "electrode planning" as reported in the journal article is off-label use of the biopsy application.The "cranial software package" on the navigation system includes software for electrode and probe placement procedures.The journal article concluded: the o-arm can be easily incorporated into standard frame-based and frameless dbs surgery with simple technical modifications.This imaging technique has been shown to provide accurate depictions of lead locations and has the potential to reduce the number of malpositioned dbs electrodes that might require subsequent revision surgery.

• 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 ; 7208902338
• MDR Report Key: 5693638
• MDR Text Key: 46363777
• Report Number: 1723170-2016-01040
• Device Sequence Number: 1
• Product Code: HAW
• 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,health
• 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: 06/01/2016
• 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: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2011
• 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
• Patient Age: 33 YR