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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7 STAFF ASSEMBLED INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC S7 STAFF ASSEMBLED INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problems Human-Device Interface Problem (2949); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 9733575, serial/lot #: unk. A medtronic representative went out to the site and found a hardware failure noting that the camera localizer was not responding. They replaced the camera localizer cable to main cart, and now the localizer is working now and instruments tracking correctly. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used outside of a procedure. It was reported that the site was having intermittent "localizer not connected " behavior issues. There was no patient involved.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Initial reporter was a biomed from the site. Name of initial reporter unknown at the time of report. The cable 9733575 ext scu to r/a psu (170928) was returned for analysis. Analysis found that the cable had been pinched near the right angle connector, but was otherwise intact. The cable passed a continuity test with no opens or shorts detected. There was no problem found. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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Brand NameS7 STAFF ASSEMBLED
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 Key9934363
MDR Text Key186817108
Report Number1723170-2020-01173
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
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 05/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2020
Was Device Evaluated by Manufacturer? Yes
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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