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

Model Number	9733068
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been returned for analysis at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a cranial biopsy.It was reported that the site was having issues tracking the biopsy needles.Multiple health care professionals (hcp) attempted to trouble shoot the issue but nothing resolved the issue, the site tried using another biopsy needle but that one didn¿t work either.The site decided to advance the needle to biopsy without live tracking update of the needle position, opting to follow the plan and the guide stop measurement calculated from the targeting aspect of the procedure.The procedure was delayed less than an hour.No impact on patient outcome.
Additional Manufacturer Narrative
The biopsy needle was returned to the manufacturer for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The biopsy needle was found to be fully functional with normal tracking.No problems found.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a cranial biopsy.It was reported that the site was having issues tracking the biopsy needles.Multiple health care professionals (hcp) attempted to trouble shoot the issue but nothing resolved the issue, the site tried using another biopsy needle but that one didn¿t work either.The site decided to advance the needle to biopsy without live tracking update of the needle position, opting to follow the plan and the guide stop measurement calculated from the targeting aspect of the procedure.The procedure was delayed less than an hour.No impact on patient outcome.

• Brand Name: S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8001637
• Report Number: 1723170-2018-05332
• Device Sequence Number: 13729373
• Product Code: HAW
• UDI-Device Identifier: 00643169546820
• UDI-Public: 00643169546820
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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 Expiration Date: 02/23/2020
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066505418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1