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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PASSIVE PLANAR PROBE, BLUNT; INSTRUMENT, STEREOTAXIC
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MEDTRONIC NAVIGATION, INC PASSIVE PLANAR PROBE, BLUNT; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 960-556
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/04/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information that, while outside of a procedure, the blunt passive planar probe was damaged.There was no patient present when this issue was identified.
 
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Brand Name
PASSIVE PLANAR PROBE, BLUNT
Common Device Name
INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key9306117
Report Number1723170-2019-05552
Device Sequence Number2448268
Product Code HAW
UDI-Device Identifier00673978090122
UDI-Public00673978090122
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K972398
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number960-556
Device Catalogue Number960-556
Device Lot Number160511
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/04/2019
Initial Report FDA Received Date11/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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