MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHCONNECT SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9735659
Medical Device Problem Codes	Computer Software Problem (1112); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.On 04/19/2017 software investigation was completed.This issue was found related to a software issue and was documented in a medtronic software anomaly tracking database.
Event or Problem Description
A medtronic representative reported that during in-house testing using stealthconnect, negative decimal numbers entered into plan task round to nearest whole number.Crosshairs do not always update.The software does not allow fractional numbers in the trajectory, negative direction.When wanting to move in the negative direction at.1 millimeter increments, it only goes to whole numbers.If the crosshairs are on the plan trajectory and the user enters a value of -0.5 < x <0 in the "mm to target" field, the millimeter to target value of -0.5 < x <0 and the crosshairs update to 0.If the crosshairs are past the plan (e.G.Mm to target is +1) and the user enters a value of -0.5 < x <0 in the "mm to target" field, the millimeter to target value remains as entered (does not round to zero) and the crosshairs do not update.Additional engineering investigation: if the user enters a negative decimal number for the depth line edit value and the value falls between the entry and target of the plan, the depth line edit value will be rounded to the nearest integer and the crosshairs set to that rounded value.If the crosshairs are positioned past the target (not between the entry and target) and the user enters a negative depth line edit value that rounds to 0 (-0.4 >= x <= 0), the crosshairs will not move and the depth line edit value will remain as the value the user entered.This issue did not occur in a clinical setting.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Product updated to proper value.

• Brand Name: STEALTHCONNECT SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6547512
• Report Number: 1723170-2017-01823
• Device Sequence Number: 19125171
• Product Code: HAW
• UDI-Device Identifier: 00643169625532
• UDI-Public: 00643169625532
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 9735659
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1