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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 Environmental Compatibility Problem (2929); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 12/30/2019
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 9735773, serial/lot #: (b)(4); product id: 9735787, serial/lot #: (b)(4). No patient involved. No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used outside of procedure. The battery was not holding a charge and was showing the battery service error message. The system was recently installed. No patient present.
 
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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 Key9606775
MDR Text Key184327468
Report Number1723170-2020-00183
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2019
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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