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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cerebrospinal Fluid Leakage (1772); Nerve Damage (1979); Loss of Vision (2139); Therapeutic Response, Decreased (2271); Meningitis (2389); Iatrogenic Source (2498)
Event Date 05/17/2016
Event Type  Injury  
Manufacturer Narrative
Patient specific ages were not provided; aged from 18 to 74 years and median of 55 years. Therefore, 55 was used. Patient sex was not made available. The male sex selected addresses the 42 males and 28 females in this study. Event date is approximated as the exact dates were not made available. The journal article was accepted for publication on 05/17/2016 and therefore used as the event date. Citation: catapano, g. , de notaris, m. , maria, d. , fernandez, l. A. , di nuzzo, g. , seneca, v. , iorio, g. , & dallan, i. (2016). The use of a three-dimensional endoscope for different skull base tumors: results of a preliminary extended endonasal surgical series. Acta neurochirurgica, 158(8), 1605-1616. Doi:10. 1007/s00701-016-2847-8 brand name, common device name and procode not provided in attached journal article. The article mentions a navigation system (model not specified). Further information unavailable. Those selected are suspected to be for the device used. Attempts have been made to obtain additional information. No additional information has been provided. Per the article, although they observed five cases of postoperative cerebrospinal fluid (csf) leaks, they believe this complication was related to the approach itself and not to the device. No request for service have been received from the customer regarding these events. No parts have been replaced or returned to the manufacturer. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic's navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
 
Event Description
Per attached article, forwarded by a medtronic representative, the use of the navigation system was reported. A retrospective review of 3-d extended endoscopic endonasal procedures for a variety of consecutive skull base lesions performed. The study focused on our experience with extended endonasal approaches using both standard resolutionand hd 3-d scopes. A total of 72 procedures (two patients needed a second surgical procedure, a clival chordoma and a giant parasellar macroadenoma, respectively) were performed (table 1). The extended endonasal approaches combined with the new 3-d endoscopic technology offer an adequate and satisfactory option in selected intra- and extradural skull base lesions. The series consisted of 42 males and 28 females, aged from 18 to 74 years (median, 55 years). All of the procedures were performed with a 3-d endoscope (visionsense) and under the guidance of the neuronavigation system using both mri or ct data and in selected cases we utilized the intraoperative ceretom® portable ct scanner that allowed non-contrast, angiography, and contrast perfusion scans (fig. 1). Total tumor removal, as assessed by postoperative magnetic resonance imaging (mri), was possible in 50 patients (71. 4 %), in 14 (20 %) patients subtotal removal (<20 % residual) was possible, whereas in six patients (8. 6 %) only partial removal (>20 % residual) was achieved (table 2). Overall complications included diabetes insipidus in eight patients (11. 4 %), hypopituitarism in seven patients (10 %), csf leak in five patients (7. 1 %), cranial nerve injury in two patients (2. 8 %), panhypopituitarism in two patients (2. 8 %), meningitis in one patient (1. 4 %), and one patient (1. 4 %) had a postoperative occlusion of the central retinal artery. There was no mortality in the series. All the data concerning tumor types and postoperative complications are collected in table 3. Concerning nasal complications, mild epistaxis occurred in 5 % of patients in the immediate postoperative time. This was solved with nasal packing for 24¿48 h. In relation to specific cases, six of the seven tuberculum sellae meningiomas (figs. 2 and 3) were completely removed (video 1), in the other case the risk of morbidity due to tumor consistency was deemed to be too high to carry out total removal of the lesions. (fig. 4) as regards to the suprasellar lymphoma, the patient underwent transsphenoidal resection of the suprasellar mass. The lesion was a firm gray lesion that filled the sella turcica, eroded the central sellar floor, and extended to the suprasellar region and he was further treated with pituitary hormone replacement and radiosurgery. Surgery for functioning lesions was highly effective in improving alterations in vision and compressive symptoms, but was unable to restore normal pituitary function in all cases. Only one case of acth-secreting adenomas was radically removed; in the other case, an extremely infiltrative nature of this tumor makes complete surgical removal impossible. Visual deficit improved in all patients but four. Concerning recurrence and thus reoperation, only one (1. 4 %) patient with a giant macroadenoma and one with clival chordoma (1. 4 %) had clinical and neuroradiological recurrence and were reoperated. Postoperative lumbar drainage was used in all cases except for eight parasellar macroadenomas and six chordomas. Postoperative cerebrospinal fluid leak occurred in five patients (7. 1 %). Within this group, two patients had, respectively, a tuberculum sellaemeningioma and a craniopharyngioma. The remaining three patients had a large suprasellar macroadenoma in two cases (one prl-secreting and the other non-functioning) and a clivus chordoma in one case. Postoperative lumbar drainage was placed in three of these five patients. The most important postoperative complication was an occlusion of the central retinal artery with consequent unilateral postoperative visual loss in a patient who had undergone a tuberculum sellae meningioma surgery; however, the anatomical integrity of the optic nerve was completely preserved (fig. 2). Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic's navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL 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
oksana ditolla
826 coal creek circle
louisville, CO 80027
MDR Report Key6440810
MDR Text Key71095769
Report Number1723170-2017-01357
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/28/2017 Patient Sequence Number: 1
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