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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC I7 INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC I7 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9734060
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: 960-539. Guide biopsy. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used during cranial biopsy. It was reported that the precision aiming device (pad) closest to the arm was difficult to tighten and it slipped on them one time when they were about to use the biopsy needle. They reseated it and proceeded with the biopsy they did prior to the laser ablation. There was no impact to the patient at the time of the event.
 
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Brand NameI7
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9454467
MDR Text Key174336347
Report Number1723170-2019-05973
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734060
Device Catalogue Number9734060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2020
Was Device Evaluated by Manufacturer? No
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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