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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC.; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC.; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9733068
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2019
Event Type  malfunction  
Event Description
Prior to use in stereotactic biopsy of the left cerebral peduncular, a biopsy needle was discovered before it was used on the patient to have a defect.This needle has a puck with a set screw that serves as a depth gauge.The set screw when fully tightened did not engage the needle so there was no way to lock the puck in place.There was a delay of about 15 minutes as the nurse attempted to get a replacement from case carts.The biopsy needle was given to the supply specialist who has arranged for the medtronic representative to pick the needle up today for return to medtronic for inspection.
 
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Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC.
826 coal creek cir.
louisville CO 80027
MDR Report Key9259674
MDR Text Key164427874
Report Number9259674
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9733068
Device Lot Number066513519C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/23/2019
Event Location Hospital
Date Report to Manufacturer10/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age17520 DA
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