MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC WRKSTN, 9732585, STLTHSTN INAV II; INSTRUMENT, STEREOTAXIC

Model Number	9732585
Medical Device Problem Codes	Imprecision (1307); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: patient information was unavailable from the site.Device evaluated by mfr: onsite functional and visual examination was performed by a manufacturer representative.The system passed a system checkout and was determined to be fully operational.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On 2019-2-05, (b)(4) (hcp rep for): medtronic received information regarding a navigation device being used for a cranial biopsy.It was reported that the site used the mr to plan and perform navigation.During the procedure there were no signs of inaccuracy.The site took a post-op ct scan and noticed they had unsuccessfully performed the surgery, and biopsied healthy tissue.The site merged the ct with the mr and it showed a 5mm deviation from target planned.There was no reported delay to procedure.The site had to schedule another surgery and was performed without medtronic navigation.It was noted that the likely cause of the event was a distorted mr scan.
Additional Manufacturer Narrative
The software investigation was unable to determine the probable cause of the reported issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a cranial biopsy.It was reported that the site used the mr to plan and perform navigation.During the procedure there were no signs of inaccuracy.The site took a post-op ct scan and noticed they had unsuccessfully performed the surgery, and biopsied healthy tissue.The site merged the ct with the mr and it showed a 5mm deviation from target planned.There was no reported delay to procedure.The site had to schedule another surgery and was performed without medtronic navigation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: WRKSTN, 9732585, STLTHSTN INAV II
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8495062
• Report Number: 1723170-2019-01618
• Device Sequence Number: 13718821
• Product Code: HAW
• UDI-Device Identifier: 00613994110831
• UDI-Public: 00613994110831
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9732585
• Device Catalogue Number: 9732585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 02/04/2019; 05/15/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 04/09/2019; 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention