MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTH AUTOGUIDE SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 29631

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Unique device identifier (udi) is unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is unavailable.Other relevant device(s) are: product id: 28322, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while in an electrode and probe placement procedure, the patient bled more than anticipated.It was suspected the issue was due to an increased incision size for the drill guide.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.Medtronic received information that the incision was 6mm which was larger than the anticipated 3mm incision for stereoelectroencep halography (seeg) procedures.Additionally, it was suspect that the surgeon was tapping the drill guide against tissue rather than bone as indicated in the workflow for the automated guidance unit.Additionally, no additional intervention was required for the bleed.

• Brand Name: STEALTH AUTOGUIDE SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9643973
• MDR Text Key: 177145913
• Report Number: 1723170-2020-00283
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29631
• Device Catalogue Number: 29631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Weight: 78