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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735665
Device Problem Imprecision (1307)
Patient Problems Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Iatrogenic Source (2498); Unspecified Nervous System Problem (4426)
Event Date 04/20/2018
Event Type  Injury  
Manufacturer Narrative
Udi not available for this system at time of filing. No parts have been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that there was inaccuracy during a sacroiliac and thoracolumbar procedure. For the procedure the surgeon was using the navigation system to navigate a pedicle access kit (pak) and a tap. The surgeon was also using a non-medtronic driver and screws which were placed without the use of the navigation system. It was stated that the surgeon ¿did not claim any issues with accuracy during surgery¿. The manufacturing representative that was present during the surgery stated that ¿he noticed visually that the tap trajectory appeared to be breaching the pedicel and asked the surgeon if they wanted to continue using that pathway and trajectory in which the surgeon stated yes¿. After the non-medtronic screws were placed the surgeon used a non-medtronic interbody with a medtronic navigated frame component tracker to place a non-medtronic implant. There was no delay to the surgery. It was reported approximately two weeks later the patient was claiming neurological deficits post-operatively following this procedure.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the reported issue could not be replicated. The system then passed the system checkout and was found to be fully functional.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided. Correction: product and related fields updated to proper value.
 
Manufacturer Narrative
A software analysis was initiated. The software analysis concluded that the software functioned as designed following review of the reported issue.
 
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Brand NameSTEALTHSTATION S8 PREMIUM 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
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7560505
MDR Text Key109774108
Report Number1723170-2018-02395
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735665
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2018
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: 06/01/2018 Patient Sequence Number: 1
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