MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) DOUBLE STAR ADAPTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	960-535
Medical Device Problem Codes	Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number unavailable.Device manufacturing date is dependent on lot number, therefore, unavailable.A replacement part was shipped to the site.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that, while in a laser induced thermal therapy (litt) procedure, it was found that the double star adapter teeth were worn out and causing movement.The site replaced the adapter and re-registered the patient and then was able to proceed with the procedure.No additional information was provided.There was a reported delay to the procedure of 30 minutes due to this issue.There was no impact on patient outcome.
Additional Manufacturer Narrative
Additional information: device lot number provided.The device was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: DOUBLE STAR ADAPTER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6767908
• Report Number: 1723170-2017-03212
• Device Sequence Number: 19336152
• Product Code: HAW
• UDI-Device Identifier: 00681490915939
• UDI-Public: 00681490915939
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K954276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: Physician
• Device Catalogue Number: 960-535
• Device Lot Number: 103820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 84