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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM FUSION EM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM FUSION EM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FUSION
Device Problem No Display/Image (1183)
Patient Problems Cerebrospinal Fluid Leakage (1772); Iatrogenic Source (2498)
Event Date 11/15/2016
Event Type  Injury  
Manufacturer Narrative
The investigation into this event is ongoing.
 
Event Description
A medtronic representative reported that during a cranial procedure the patient experienced a csf leak. The surgeon reported that the screen of the navigation system went "off" and acted weird so the surgeon re-registered the blade and everything was fine. No further details regarding the event or patient status were provided. The medtronic representative was unsure of what procedure was being performed but knows that the navigation system was in use.
 
Manufacturer Narrative
The issue was reviewed during the hardware engineering investigation meeting. No additional details were provided to explain the reported issue/malfunction. No hardware parts were replaced, at this time there is no confirmed allegation of deficiency related to hardware components. No further hardware investigation shall take place at this time. If additional information is received related to the hardware investigation the formal investigation will be re-reviewed. Recommend software review. The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.
 
Manufacturer Narrative
Correction: event date updated to proper value.
 
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Brand NameSYSTEM FUSION EM
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
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902338
MDR Report Key6183454
MDR Text Key62670387
Report Number1723170-2016-05769
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 06/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560
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 Received05/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2016
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: 12/16/2016 Patient Sequence Number: 1
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