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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC 1.5MM PASSIVE PLANAR BALL PROBE; INSTRUMENT, STEREOTAXIC
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MEDTRONIC NAVIGATION, INC 1.5MM PASSIVE PLANAR BALL PROBE; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 960-559
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/11/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.Device manufacture date is unavailable.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 passive planar probe tip was visibly bent.There was no patient present when this issue was identified.
 
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Brand Name
1.5MM PASSIVE PLANAR BALL PROBE
Common Device Name
INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key8769234
Report Number1723170-2019-03980
Device Sequence Number1832610
Product Code HAW
UDI-Device Identifier00673978090153
UDI-Public00673978090153
Combination Product (Y/N)N
Initial Reporter StateIN
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/08/2019
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 Number960-559
Device Catalogue Number960-559
Device Lot Number080129
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/11/2019
Initial Report FDA Received Date07/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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