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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC 2 COIL STYLET NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC 2 COIL STYLET NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735428
Device Problem Biocompatibility (2886)
Patient Problem Unspecified Infection (1930)
Event Date 10/22/2021
Event Type  Injury  
Manufacturer Narrative
Patient information was unavailable from the site. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used during a procedure. It was reported that an infection occurred during the procedure utilizing the navigation stylet. There was no reported delay to the procedure due to this issue.
 
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Brand Name2 COIL STYLET
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12814757
MDR Text Key280789257
Report Number1723170-2021-02693
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K141833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735428
Device Catalogue Number9735428
Device Lot Number210430A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/15/2021 Patient Sequence Number: 1
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