• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC S7 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problem Protective Measures Problem (3015)
Patient Problem No Patient Involvement (2645)
Event Date 06/06/2019
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Other relevant device(s) are: product id: 9734639, serial/lot #: (b)(4). The manufacturer representative went to the site to test the navigation system. The reported issue was confirmed and parts were replaced. The power cable was returned to the manufacture for evaluation. After functional testing and visual/physical examination the reported issue was confirmed. The returned cable has two cuts in the cable jacket exposing the internal wires including the bare conductors in one place. Otherwise, the cable passed a continuity test with no opens or shorts detected. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported outside of a procedure that the system had a damaged power cable. No patient was present at the time of the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameS7
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 Key8749749
MDR Text Key149685922
Report Number1723170-2019-03888
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
Reporter Occupation
Type of Report Initial
Report Date 07/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-