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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733858
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 06/28/2019
Event Type  Injury  
Manufacturer Narrative
Patient weight was unavailable from the site. The unique identifier was not none at the time of the event. Report source- foreign country: (b)(6). No parts have been received by the manufacturer for evaluation. (b)(4). The manufacture date was not known at the time of the event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a procedure. It was reported that the patient was in the operating room and had undergone tracheal intubation combined with intravenous inhalation of general anesthesia with the fixed frame installed at the head. It was planned to perform the preoperative surgical plan and when the deep intracranial lead was placed the screen of the surgical navigation system appeared with a flash screen and then a black screen appeared. After rebooting the screen was still black and it was impossible to continue the operation plan. It was noted that there was a surgical bed failure. There was impact to the patient and the patient outcome was serious injury. Update from the manufacturer representative stating that this event was feedback by cfda not customer. All ae in china is not public information, we can¿t get further information due to government reason.
 
Manufacturer Narrative
Additional information was added to the event description. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received stating that the site stopped using it, and the device was repaired by the manufacturer representative. It was detected that it was the malfunction of the operation guide system circuit system and the motherboard failure. After maintenance the replaced the part the device could be normally used. The reported issue caused pain to the patient.
 
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Brand NameSTEALTHSTATION® S7
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 Key8921616
MDR Text Key155235440
Report Number1723170-2019-04599
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCH
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 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733858
Device Catalogue Number9733858
Device Lot Number3220399
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? No
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: 08/22/2019 Patient Sequence Number: 1
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