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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10)

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10) Back to Search Results
Model Number S7
Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2017
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The representative was unable to replicate the reported issue. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
Manufacturer Narrative
The polaris spectra system control unit (scu) was returned to the manufacturer for evaluation. After functional testing and visual/physical examination the reported issue could not be confirmed. The scu performed as expected with no issues. A check of the event logs did not reveal any adverse events. No problem was found. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used in a cranial resection. It was reported that the positioning sensor unit (psu) sometime did not respond/work. The system was rebooted with resolution. There was less than an hour in delays. No impact on patient outcome.
 
Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations. No procode, common device name and/or 510k provided as this device is not released for distribution in the united states. No parts have returned to the manufacturer for evaluation. No parts returned for analysis.
 
Event Description
A medtronic representative reported that while in a cranial resection procedure the positioning sensor unit (psu) sometimes did not respond/work. The system was rebooted with resolution. The procedure was completed with navigation. There was a reported delay to the procedure of 5 minutes due to this issue and no impact on the patient outcome.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceSEE H10)
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
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7185799
MDR Text Key103043645
Report Number1723170-2018-00214
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9734056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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