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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TREON
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Edema (1820); Hemorrhage/Bleeding (1888)
Event Date 08/29/2015
Event Type  Injury  
Manufacturer Narrative
Average patient age was 54. 51% were female. No weight or ids were provided. The medtronic stealthstation navigation system listed is no longer at the site. No allegation that the system caused or contributed to the patient complications. The complications are known inherent risks to any biopsy procedure. The authors concluded the navigation system is an effective, safe, and reliable tool, which when used properly has an excellent diagnostic yield, above 95 %. Instructions for use which accompany this device state potential adverse events associated with biopsy procedures, though not necessarily associated with use of this device, include but are not limited to: fresh neurodeficit, pseudomeningocele, brain hemorrhage, and new onset seizure.
 
Event Description
In the article entitled, contemporary frameless intracranial biopsy techniques: might variation in safety and efficacy be expected?, the authors report that 5 biopsies utilizing the medtronic stealthstation were non-diagnostic. If diagnostic tissue was not obtained, all parameters and measurements were rechecked to ensure accurate localization, after which a repeat biopsy was performed via the same or a new trajectory if needed. When a nondiagnostic biopsy was encountered, follow-up surgery (either stereotactic or open biopsy or tumor decompression) was recommended for the some of the patients. It is also reported in table 3 that 1 percent of patients had hemorrhage, 3. 9% had edema formation, 2. 9% had focal neurology, 1% had other complications (psychosis, hyperglycemia, epilepsy, hypertension, and diabetes insipidus). Table 1 reports 2% had technical failures.
 
Manufacturer Narrative
Additional information: the surgeon reported that table 1: there were two technical failures: in one patient the biopsy needle was not vacuum and therefore the biopsy was not adequate. Another needle was then used; in the other patient the biopsy-arm was not functioning correct. The ball-in-socket joint was too tight. The surgery could be performed and the arm was repaired the next day. The hemorrhages and/or the non-diagnostic biopsies cannot be related to either biopsy system equipment. It is just inherent to the surgery itself. Unfortunately, i cannot provide you with patient details.
 
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Brand NameSTEALTHSTATION TREON TREATMENT GUIDANCE 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
amos jarrette
826 coal creek circle
louisville, CO 80027
7208902082
MDR Report Key5411895
MDR Text Key37525490
Report Number1723170-2016-00160
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTREON
Device Catalogue Number9680111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/05/2004
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: 02/04/2016 Patient Sequence Number: 1
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