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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UPGRADE PRGM 9734261 STEALTHSTATION S7 NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UPGRADE PRGM 9734261 STEALTHSTATION S7 NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problems Unstable (1667); Device Operates Differently Than Expected (2913)
Patient Problems Tissue Damage (2104); Iatrogenic Source (2498)
Event Date 07/26/2017
Event Type  Injury  
Manufacturer Narrative
Additional information: patient weight now provided. The exact numerical weight is (b)(6) kg. Correction: the procedure was aborted after an incision had already been made. Also, it was inadvertently reported on the initial mdr in describe event or problem that "tracking was not inconsistent as the instruments were flickering on tracker details" and should instead have stated that "tracking was inconsistent as the instruments were flickering on tracker details. ".
 
Manufacturer Narrative
Patient weight not available from the site. A medtronic representative went to site to test the equipment. Representative reported that the site confirmed that there was a video tower behind the emitter during surgery. A system checkout was performed. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. -no parts were replaced. -no parts have been received by manufacturer for evaluation. Per further engineering review of the reported event it was confirmed that the system is working as intended. The probable cause was determined to be operational technique as there was a video tower positioned behind the emitter during a case. The instructions for use (ifu) contains warnings regarding metallic objects near emitter. "caution: metallic objects in or near the navigation field can degrade navigational accuracy. If metallic distortion causes excessive error, navigation will be disabled. To restore navigation, remove metallic objects from the navigation field. ".
 
Event Description
A medtronic representative reported that during a shunt placement procedure with axiem the instrument/reference tracking was not inconsistent as the instruments were flickering on tracker details. Site informed that there was a video tower behind the emitter which reduced the tracking field due to metal in the field. The navigation was aborted and the surgery was rescheduled. There was a delay of less than 1 hour.
 
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Brand NameUPGRADE PRGM 9734261 STEALTHSTATION S7
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
oksana ditolla
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key6817221
MDR Text Key102488230
Report Number1723170-2017-03454
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150216
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
Report Date 09/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9734261
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 Received08/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2011
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: 08/24/2017 Patient Sequence Number: 1
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