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 Unspecified Infection (1930); Iatrogenic Source (2498)

Event Date 06/20/2015

Event Type  Injury  

Manufacturer Narrative

The mean age was 63.6 ± standard error of the mean (sem) 15.7 years and 60% of patients were males.Patient id's and weight were not provided.Citation: sharma m, deogaonkar m.Accuracy and safety of targeting using intraoperative ¿¿o-arm¿ during placement of deep brain stimulation electrodes without electrophysiological recordings.J clin neurosci (2016), http://dx.Doi.Org/10.1016/j.Jocn.2015.06.036.No allegation of a product problem.Therefore no evaluation will be performed.

Event Description

The aim of the study was to investigate the accuracy of targeting using intraoperative ¿¿o-arm¿ during deep brain stimulation (dbs) surgery.Intraoperative o-arm (medtronic, (b)(4)) images were obtained to confirm the accuracy of placement.The difference between intended and actual target coordinates was calculated based on intraoperative images and postoperative ct scan.Euclidian vector error was obtained to estimate the directional error.Correlation of targeting error with the pneumocephalus and the deviation from the planned trajectory was also estimated.Twenty eight dbs leads (globus pallidus internus [gpi], n = 13; subthalamic nucleus [stn], n = 9; ventralis intermedius nucleus [vim], n = 6) were implanted in 20 patients using the stereotactic leksell frame (elekta (b)(4)) under general anesthesia over a period of 1 year.The mean age was 63.6 ± standard error of the mean (sem) 15.7 years and 60% of patients were males.The mean absolute difference (+sem) between intended and actual target in x, y and z coordinates based on intraoperative ct scan was 0.65 ± 0.09 (p = 0.84), 0.58 ± 0.08 (p = 0.98), 1.13 ± 0.10 (p = 0.08), respectively, and postoperative (1 month) ct scan was 0.82 ± 0.15 (p = 0.89), 0.55 ± 0.11 (p = 0.97), and 1.58 ± 0.29 (p = 0.08), respectively.The euclidean vector error was 1.59 ± 0.10 and 2.16 ± 0.26 based on intraoperative and postoperative images, respectively.There was no statistically significant targeting error based on fusion of intraoperative ct images to either preoperative ct scan or mri as registration series, the presence of pneumocephalus, deviation from planned trajectory or the anatomical target (stn versus vim versus gpi) (p > 0.05).Superficial skin infection was encountered in a single patient in this study.The mean total operating room time was 193.5 ± 74.6 minutes.The distance between two contacts on dbs electrode model 3389 is 2 mm; therefore targeting error of >2 mm implies displacement of approximately one contact and was considered as a threshold for repositioning the lead.None of the dbs electrodes in this study had a displacement of >2 mm requiring repositioning.A single case of superficial infection was noted 3 weeks after the surgery which required removal of the dbs system.Another patient with parkinson¿s disease developed swallowing difficulties secondary to difficult intubation and trauma to the airway following unilateral gpi dbs.She required a percutaneous endoscopic gastrostomy tube and her swallowing function gradually improved over 3 months.No other intraoperative or postoperative complications were encountered in this study patient complications reported are inherent risks to cranial surgery and were not related to use of medtronic system.Conclusion dbs leads can be implanted safely and with accuracy using intraoperative o-arm with a frame based targeting system.Intraoperative o-arm provides three-dimensional accuracy and can be used in selected patients who cannot tolerate awake procedures.Frequent use of this imaging modality is required to master the nuances associated with this technology in the operating room.Randomized controlled studies with large sample size are required to validate the efficacy of intraoperative o-arm during dbs implantation surgery.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's o-arm or stealthstation.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported 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: catherine eaton ; 826 coal creek circle; louisville, CO 80027 ; 7208902092
• MDR Report Key: 5507946
• MDR Text Key: 40592105
• Report Number: 1723170-2016-00371
• 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: health professional,literatur
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• 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: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: O-ARM 1000 IMAGING SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR