MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734894 S7 STAFF AXIEM ONLY 110V; INSTRUMENT, STEREOTAXIC

Model Number	9734894
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the software 9735585 stealthstation cranial (unknown serial/lot #) found no failure.Product event summary #s7 used with visualase inaccuracy placement of laser fiber.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system event having occurred intra-operatively of an electrode and probe placement.It was reported that the site reported that the laser fiber was placed 2mm left inaccurate using the leskell frame.They repositioned and it was still off plan.Surgeon continued with case with laser fiber placement being adequate for his purpose.No impact to patient and less than an hour of delay reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CART 9734894 S7 STAFF AXIEM ONLY 110V
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8710185
• Report Number: 1723170-2019-03557
• Device Sequence Number: 16605637
• Product Code: HAW
• UDI-Device Identifier: 00643169105232
• UDI-Public: 00643169105232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9734894
• Device Catalogue Number: 9734894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 58