MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number TREON

Device Problems Imprecision (1307); Patient-Device Incompatibility (2682)

Patient Problems Spinal Column Injury (2081); Weakness (2145); Iatrogenic Source (2498)

Event Date 01/19/2015

Event Type  Injury  

Event Description

Reported issue identified through a review of the journal article: comparison of non-navigated and 3-dimensional image-based computer navigated balloon kyphoplasty.Jonathan n.Sembrano, md; sharon c.Yson, md; david w.Polly jr, md; charles gerald t.Ledonio, md; david j.Nuckley, phd; & edward r.G.Santos, md reported that one patient in the navigated group who had osteoporotic compression fracture of t4 and t6 had right lower extremity weakness on waking from the procedure.Needle position could not be adequately assessed based on intraoperative 3-dimensional scans because of poor bone density and significant surrounding soft tissue (obesity).Paravertebral cement leakage occurred at both operative levels.The patient underwent emergency laminectomy, regained partial strength of the right lower extremity, and was able to ambulate independently with a walker at the time of hospital discharge.Although a single event in a relatively small number of cases does not suggest statistical correlation, this finding should be enough to dampen enthusiastic conclusions favoring navigation.More than 1 fracture level (t4 and t6) occurred in this case, and the patient was both obese and very osteopenic.It is not certain whether the same complication would have occurred or whether the surgeon would have abandoned the procedure for lack of clear visualization without navigation.However, the most important concerns for the authors' surgical team were where and how to place the reference frame of the navigation system.Before this case, the reference frame was simply taped over the skin with strips of antimicrobial surgical incise drape (loban; 3m, st.Paul, minnesota) in most navigated cases (7 of 9).This was done to avoid making a longer additional skin incision for what was supposedly a percutaneous procedure.After this single and serious complication, the authors abandoned the "skin taping" technique because they believed that this may have affected the accuracy of the navigation.All subsequent navigated procedures were performed with the reference frame either clamped to a spinous process or fixed to the iliac crest with a percutaneous pin.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 treon treatment guidance system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Manufacturer Narrative

Patient information was not made available from the journal article.Probable cause determined to be use error due to "taping frame" to skin.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 treon treatment guidance system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event, therefore, no evaluation will be performed.

• Brand Name: STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: judi ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 4639316
• MDR Text Key: 5575084
• Report Number: 1723170-2015-00376
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: TREON
• Device Catalogue Number: 9680111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2004
• 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