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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC BIOPSY GUIDE; INSTRUMENT, STEREOTAXIC
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MEDTRONIC NAVIGATION, INC BIOPSY GUIDE; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 960-539
Medical Device Problem Code Output Problem (3005)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/30/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Patient information was asked for but unknown.The device/instrument was not returned to the manufacturer ion the date of filing.Manufacture date was not available at the time of filing.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding a navigation system.During a cranial biopsy procedure it was reported that the lock on the biopsy guide was loose.There was no delay to the procedure.There was no reported impact on patient outcome.
 
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Brand Name
BIOPSY GUIDE
Common Device Name
INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key8114661
Report Number1723170-2018-05920
Device Sequence Number252136
Product Code HAW
UDI-Device Identifier00763000055578
UDI-Public00763000055578
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K954276
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/29/2018
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 Number960-539
Device Catalogue Number960-539
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/31/2018
Initial Report FDA Received Date11/29/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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