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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC THORACIC PROBE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC THORACIC PROBE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734680
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
The probe was returned to medtronic for analysis. Analysis revealed that the tip of the returned probe was bent. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database. If information is provided in the future, a supplemental report will be issued.
 
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 Description
Medtronic received information that, while outside of a procedure, the thoracic probe was damaged. There was no patient present when this issue was identified.
 
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Brand NameTHORACIC PROBE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
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 Key9431267
MDR Text Key182056120
Report Number1723170-2019-05891
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K124004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734680
Device Catalogue Number9734680
Device Lot Number191016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2019
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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