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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MAIN CART 9735669 STEALTH S8 EM ENT INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC MAIN CART 9735669 STEALTH S8 EM ENT INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735669
Device Problems Computer Software Problem (1112); Data Problem (3196)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Concomitant medical product: sfw kit 9735736, stealth s8 ent. The software investigation found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software tracking database. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used outside of procedure, with no patient present. It was reported that while the site attempted to archive a patient, the received transfer failed. A manufacturer representative (rep) found that there was an exam tied to the patient with 0 slices. After deleting the extra exam, the issue was resolved and the site was able to export.
 
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Brand NameMAIN CART 9735669 STEALTH S8 EM ENT
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 Key8661614
MDR Text Key146813786
Report Number1723170-2019-02860
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735669
Device Catalogue Number9735669
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2016
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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