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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
Medical Device Problem Code Device Sensing Problem (2917)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/06/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been returned to the manufacturer for analysis.Parts not returned.
 
Event or Problem Description
Medtronic received information regarding a navigation device being used for a cranial resection procedure.The issue occurred intraoperatively and delayed the surgery by 20 minutes.It was reported that the em stylet has recognition failure.The em stylet was replaced with a new one and the replaced one could be recognized normally.The surgery was completed with navigation and there was no impact on patient outcome.
 
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Brand Name
STEALTHSTATION S7 SYSTEM
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key7732958
Report Number1723170-2018-03748
Device Sequence Number11114081
Product Code HAW
UDI-Device Identifier00643169505735
UDI-Public00643169505735
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K050438
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2018
Initial Report FDA Received Date07/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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