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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PASSIVE PLANAR BLUNT PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PASSIVE PLANAR BLUNT PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 960-556
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Date 06/07/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. The probe was returned to the manufacturer for analysis. Analysis found that the tip of the returned probe was visibly bent. However, with markers attached and fully seated, the probe returned a good geometry error and only a slightly elevated divot error that still allowed verification. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
Event Description
Medtronic received information regarding a navigation device being used outside a procedure. It was reported that the tip om the passive planar blunt probe was bent. There was no patient present when this issue was identified.
 
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Brand NamePASSIVE PLANAR BLUNT PROBE
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
heather davis
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7661174
MDR Text Key113174018
Report Number1723170-2018-03138
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 07/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number960-556
Device Lot Number120806
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2012
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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