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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 Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2016
Event Type  malfunction  
Manufacturer Narrative
Patient information was not made available from the site.On 11/09/2016, a medtronic representative performed a navigation system check-out.Reported issue could not be replicated.System performed as intended.Conducted investigation with the site operating room (or) team and they are sure that the surgeon has accidentally moved the reference frame.Determined this to be a user error.No further issues have been reported.
 
Event Description
A site physician alleged that, while in a spinal fusion procedure, an inaccuracy occurred.This was a minimal invasive procedure.Reference was placed on the iliac crest.Pak needle navigation was on l2, on the navigation system surgeon monitor, the pak needle blue representation suddenly moved more lateral, approximately 2 centimeters, for no apparent reason.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.
 
Manufacturer Narrative
Patient information now provided.The instructions for use (ifu) which accompanies this device contains the following warnings regarding frame movement: "warning: make sure that the reference frame assembly is rigidly attached and locked (tightened) with respect to the relevant anatomy.If the post or clamp moves in relation to the anatomy, navigational inaccuracy may result." and "warning: do not bump or reposition the reference frame after registration.Such movement may result in inaccurate navigation.If the reference frame moves in relation to the patient anatomy at any time after registration, you must reregister.".
 
Manufacturer Narrative
The suspect device was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
 
Manufacturer Narrative
Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: 9733686, version #: 2.1.0 (software); product id: 9733498nav, lot/serial #: unknown (sphere).H3) the software analysis found that the behavior described is the intended behavior of the software.Software is functioning as designed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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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
MDR Report Key6138020
MDR Text Key61245362
Report Number1723170-2016-05613
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450968
UDI-Public00613994450968
Combination Product (y/n)N
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2017
Date Manufacturer Received09/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
Patient Weight84
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