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

Model Number	9733879
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.Device has not been returned to the manufacturer for analysis.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 resection procedure.It was reported there was deformation of tip of the linear blunt probe.A passive probe was used instead.This issue was noted preoperatively and did not cause any surgical delay.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
The linear blunt probe was returned to the manufacturer for analysis.Analysis found the tip of the returned probe is slightly bent.Otherwise, the probe functioned as intended.Analysis found that the reported event was related to a physical damage issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8353989
• Report Number: 1723170-2019-00712
• Device Sequence Number: 19382667
• Product Code: HAW
• UDI-Device Identifier: 00613994480613
• UDI-Public: 00613994480613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/05/2019

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: 9733879
• Device Catalogue Number: 9733879
• Device Lot Number: 141209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1