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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 Problems Tissue Damage (2104); Brain Injury (2219); Therapeutic Response, Decreased (2271); Iatrogenic Source (2498); No Information (3190)
Event Date 12/29/2016
Event Type  Injury  
Manufacturer Narrative
Correction: a medtronic representative reported that some of these inaccuracies have resulted in patients coming back for re-do craniotomy. They were not able to provide how inaccurate the system was. The case was not delayed. They found at a later date that the tumor was not biopsied. They got results for normal brain tissue back from pathology. No patient demographics were provided despite multiple attempts from the surgeon and site staff. Patient codes updated. The following 3 related mdrs were submitted based on the above allegations of multiple patient events: 1723170-2017-01004, 1723170-2017-01001, 1723170-2017-01003. Additional information: a medtronic representative reported that he tested instruments and one probe was found to have slightly higher geometry error and was replaced (this probe was returned for evaluation and found to be fully functional and unrelated to the cause of the reported event). The rep found that after replacing chipped and scratched spheres, he was able to improve the instruments accuracy. He also found that "the locking mechanism on the mayfield (non-medtronic device) had play in it allowing the head to move" when he bumped in to the demo head after he had accuracy confirmed with frame, probe and demo head. Demo head moved about 1/4" caused about 2-3 mm inaccuracy. The reps checked all mayfields at site, found every one of them had slight play when it was locked. One of them had about double the movement than the others. It was recommended that the mayfields rep check out their devices. The rep also completed in-service training with the navigation coordinator at the site. The instructions for use (ifu) that accompanies the device contains warnings regarding the use of damaged spheres.
 
Manufacturer Narrative
Patient age not available from the site. Patient sex not available from the site. Patient weight not available from the site. During the onsite inspection, the medtronic representative reported that the system operated within specifications. The reported issue was not confirmed.
 
Event Description
A medtronic representative reported that the had been experiencing inaccuracies with the cranial application (specifically optical navigation).
 
Manufacturer Narrative
Additional information: a medtronic representative reported the reported issue has not reoccurred with the navigation system. It was reported that the site uses forceps to remove the spheres from the instruments which is not the recommended practice. Following the report of the forceps being used. The probable cause of the anomaly would be linked to a use error. The software investigation found that the reported event was unrelated to a software issue. The software functioned as designed.
 
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Brand NameSTEALTHSTATION S7 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
amos jarrette
826 coal creek circle
attn:product quality experienc
louisville, CO 80027
7208902082
MDR Report Key6377308
MDR Text Key102113796
Report Number1723170-2017-01002
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 11/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2010
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: 03/03/2017 Patient Sequence Number: 1
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