MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC REFERENCE FRAME 961337 SMALL PASSIVE; INSTRUMENT, STEREOTAXIC

Model Number	961-337
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that during a cranial resection procedure during registration, the registration frame would stop tracking randomly and they would move it slightly and tracking would resume.They swapped out the spheres and still the same behavior would occur.After finishing registration, they switched to another one and this one tracked without any issue.The site also had another reference frame that they tried to use as well and this one tracked without any issue as well.They resumed the case using the two good reference frames.There was a delay to the procedure of less than one hour.There was no reported impact on patient outcome.

• Brand Name: REFERENCE FRAME 961337 SMALL PASSIVE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7971896
• Report Number: 1723170-2018-05177
• Device Sequence Number: 19204525
• Product Code: HAW
• UDI-Device Identifier: 00721902467783
• UDI-Public: 00721902467783
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K974187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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: 961-337
• Device Catalogue Number: 961-337
• Device Lot Number: 140205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 59