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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 Problem Unstable (1667)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2017
Event Type  malfunction  
Manufacturer Narrative
Patient identifier field not sufficient to hold all digits, should read: (b)(6). Patient age not available from the site. Patient weight not available from the site. Device manufacturing date is unavailable. It was reported the a field representative inspected the precision aiming device (pad) and was unable to replicate the reported issue, no problems were found. No further issues reported. Product was not returned to manufacturer for analysis, therefore, no findings are possible.
 
Event Description
A medtronic representative reported that while in a catheter-based procedure, the surgeon was drilling and when he was in the process of removing the drill from the precision aiming device (pad), the vertek arm moved. They were able to proceed without issues. There was no reported delay to the procedure due to this issue. There was no impact on patient outcome.
 
Manufacturer Narrative
Product and unique device identification (udi) updated to proper value.
 
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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
amos jarrette
826 coal creek circle
attn:product quality experienc
louisville, CO 80027-9710
7208902082
MDR Report Key6450415
MDR Text Key71480564
Report Number1723170-2017-01441
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
Type of Report Initial,Followup,Followup
Report Date 07/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9734261R
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2010
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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