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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Imprecision (1307)
Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2018
Event Type  Injury  
Manufacturer Narrative
Patient information was unavailable from the site. Udi not available for this system at time of filing. No parts have been received by the manufacturer for evaluation. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a catheter placement. It was reported that the surgeon alleged that the system was inaccurate inferior to both targets. After performing an auto registration with the imaging system, the site began navigating the procedure. It was not until the surgeon reached the target, that they alleged the inaccuracy. The site aborted navigation and never got the ablation using the thermal therapy system. There was a reported delay to the procedure of less than one hour due to this issue. The site checked the surface skin for accuracy after registration, but not after they draped. They never turned the laser on.
 
Manufacturer Narrative
Initial mdr inadvertently filed as only malfunction when it should have been filed as a serious injury due to the procedure being aborted. Initial reporter's name corrected. A medtronic representative went to the site to test the equipment. Testing revealed that the system was performing as intended. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received additional information that the laser induced thermal therapy (litt) procedure was aborted after the laser was placed but prior to any ablation. The patient was under anesthesia when the procedure was aborted and it was unknown if the patient was scheduled or rescheduled for any other procedure.
 
Manufacturer Narrative
Patient demographics provided. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION S8 PREMIUM SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8031274
MDR Text Key125911284
Report Number1723170-2018-05455
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
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 Received02/13/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/01/2018 Patient Sequence Number: 1
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